cerebral palsy gait analysis surgery outcomes

cerebral palsy orthopedic surgery gait kinematics before after

cerebral palsy gait before after surgery thesis publications systematic review 2020 2025

PMID: 30918016

PMID: 34314902

PMID: 38718437

PMID: 32615408

PMID: 40540792

ls /home/daytona/workspace/ 2>/dev/null || mkdir -p /home/daytona/workspace/cp-t…

mkdir -p /home/daytona/workspace/cp-thesis && ls /home/daytona/workspace/

~/cp-thesis/generate_protocol.js

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        // ── TITLE PAGE ──────────────────────────────────────────────────────
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        blank(),
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        infoTable([
          ["Principal Investigator", "[Your Name], MS Orthopaedics Junior Resident (1st Year)"],
          ["Supervisor / Guide", "[Name], Professor & Head, Dept. of Orthopaedics"],
          ["Co-Investigator(s)", "[Name(s)]"],
          ["Institution", "GGSMCH, Faridkot, Punjab"],
          ["Protocol Version", "Version 1.0"],
          ["Date", "July 2026"],
          ["Ethics Approval No.", "[To be filled after IEC approval]"],
          ["CTRI Registration No.", "[To be filled after registration]"],
          ["Funding", "Nil (Self-funded / Institutional)"],
        ]),
        blank(),
        divider(),

        // ── SECTION 1: BACKGROUND ───────────────────────────────────────────
        h1("1. Background and Rationale"),
        body("Cerebral palsy (CP) is the most common cause of childhood physical disability, with a global prevalence of approximately 2-3 per 1,000 live births. It arises from a non-progressive lesion in the developing brain and manifests with a wide spectrum of motor deficits, the most functionally significant of which are gait abnormalities."),
        blank(),
        body("Gait abnormalities in CP result from a combination of primary impairments (spasticity, weakness, reduced selective motor control) and secondary deformities (muscle contractures, bony torsion, joint instability). These include equinus gait, stiff knee gait, crouch gait, intoeing gait, and scissor gait, often occurring at multiple levels simultaneously."),
        blank(),
        body("Orthopaedic surgical interventions - including soft tissue procedures (tendon lengthening, tendon transfers, muscle releases) and bony procedures (osteotomies, derotation procedures) - are widely employed to correct these gait deviations. Single-Event Multilevel Surgery (SEMLS) has emerged as the preferred approach, allowing correction of all deformities in one surgical episode guided by instrumented gait analysis (IGA)."),
        blank(),
        body("Despite widespread use, objective evidence on the magnitude and durability of gait improvement following surgery in Indian CP patients remains limited. Most published data originate from Western centres with access to 3D motion capture laboratories. There is a need for prospective studies at tertiary care institutions in India using validated clinical and observational gait tools to document pre- and post-operative gait changes."),
        blank(),
        body("This study aims to fill that gap by prospectively evaluating gait parameters in CP patients before and after orthopaedic surgery at GGSMCH Faridkot, using validated clinical assessment tools and observational gait scoring."),
        divider(),

        // ── SECTION 2: OBJECTIVES ───────────────────────────────────────────
        h1("2. Objectives"),
        h2("2.1 Primary Objective"),
        bullet("To evaluate and compare gait parameters in children with cerebral palsy before and after orthopaedic surgery at defined follow-up intervals (3, 6, 12, and 24 months post-operatively)."),
        blank(),
        h2("2.2 Secondary Objectives"),
        bullet("To classify patients using the Gross Motor Function Classification System (GMFCS) and assess changes in functional level post-surgery."),
        bullet("To measure spasticity (Modified Ashworth Scale), joint range of motion (goniometry), and muscle strength (MRC grade) before and after surgery."),
        bullet("To assess functional mobility using the Functional Mobility Scale (FMS) and Gross Motor Function Measure (GMFM-66/88)."),
        bullet("To document surgical complications, recurrences, and adverse events."),
        bullet("To compare outcomes between different surgical procedures (soft tissue vs. bony corrections) where applicable."),
        divider(),

        // ── SECTION 3: HYPOTHESIS ───────────────────────────────────────────
        h1("3. Hypothesis"),
        h2("3.1 Null Hypothesis (H0)"),
        body("There is no statistically significant improvement in gait parameters in children with cerebral palsy following orthopaedic surgery."),
        blank(),
        h2("3.2 Alternative Hypothesis (H1)"),
        body("There is a statistically significant improvement in gait parameters in children with cerebral palsy following orthopaedic surgery."),
        divider(),

        // ── SECTION 4: STUDY DESIGN ─────────────────────────────────────────
        h1("4. Study Design"),
        infoTable([
          ["Study Type", "Prospective Observational Cohort Study"],
          ["Study Setting", "Department of Orthopaedics, GGSMCH, Faridkot"],
          ["Study Duration", "2 years (data collection) + 6 months (analysis & write-up)"],
          ["Follow-up Duration", "Minimum 12 months post-operatively (up to 24 months)"],
          ["Study Population", "Children and young adults with cerebral palsy undergoing orthopaedic surgery"],
        ]),
        divider(),

        // ── SECTION 5: SAMPLE SIZE ──────────────────────────────────────────
        h1("5. Sample Size Calculation"),
        body("Sample size is calculated based on the expected improvement in the Edinburgh Visual Gait Score (EVGS) following surgery (primary outcome)."),
        blank(),
        body("Based on published literature (Amirmudin et al., 2019; Campbell et al., 2020):"),
        bullet("Expected mean improvement in gait score post-surgery: 10 points"),
        bullet("Standard deviation (SD): 8 points"),
        bullet("Effect size (d): 1.25"),
        bullet("Alpha (alpha error): 0.05 (two-tailed)"),
        bullet("Power (1 - beta): 80%"),
        blank(),
        body("Using paired t-test formula: n = (Z_alpha/2 + Z_beta)^2 * SD^2 / d^2"),
        body("Calculated n = approximately 26 patients"),
        body("With 20% attrition allowance: Final sample size = 32 patients", true),
        blank(),
        body("Note: Sample size should be recalculated with institutional statistician using pilot data if available."),
        divider(),

        // ── SECTION 6: ELIGIBILITY ──────────────────────────────────────────
        h1("6. Eligibility Criteria"),
        h2("6.1 Inclusion Criteria"),
        bullet("Diagnosed with cerebral palsy (spastic type - diplegia, hemiplegia, or quadriplegia)"),
        bullet("Age 4 - 18 years at time of surgery"),
        bullet("GMFCS levels I - IV"),
        bullet("Ambulatory (with or without assistive devices) at baseline"),
        bullet("Planned for orthopaedic surgery based on clinical gait evaluation and multidisciplinary team decision"),
        bullet("Informed consent obtained from parent/guardian; assent from patient (if able)"),
        blank(),
        h2("6.2 Exclusion Criteria"),
        bullet("Non-spastic types of CP (dyskinetic, ataxic, mixed) - may be included as subgroup analysis"),
        bullet("GMFCS level V (non-ambulatory)"),
        bullet("Previous orthopaedic surgery at same anatomical level within 2 years"),
        bullet("Concomitant selective dorsal rhizotomy (SDR) or intrathecal baclofen pump in same admission"),
        bullet("Active lower limb infection or wound healing problem"),
        bullet("Significant cognitive impairment precluding cooperation with gait assessment"),
        bullet("Refusal to participate or provide informed consent"),
        bullet("Likelihood of loss to follow-up (migration, residence > 200 km without regular follow-up access)"),
        divider(),

        // ── SECTION 7: PROCEDURES ───────────────────────────────────────────
        h1("7. Study Procedures"),
        h2("7.1 Enrolment and Screening"),
        bullet("All patients with CP referred to the orthopaedic outpatient department (OPD) or admitted for surgical planning will be screened."),
        bullet("Eligibility will be confirmed by the principal investigator."),
        bullet("Written informed consent will be obtained from the parent/legal guardian."),
        bullet("Baseline assessment will be conducted within 4 weeks prior to surgery."),
        blank(),
        h2("7.2 Surgical Intervention"),
        bullet("Surgery will be performed by the attending consultant orthopaedic surgeon as per standard clinical practice."),
        bullet("The type of surgery (soft tissue, bony, or combined SEMLS) will be documented in detail."),
        bullet("All intraoperative findings, techniques, implants used, and operative time will be recorded."),
        blank(),
        h2("7.3 Post-operative Care"),
        bullet("Post-operative immobilisation, physiotherapy protocol, and rehabilitation will follow standard departmental guidelines."),
        bullet("All post-operative complications (wound, infection, neurovascular, implant-related) will be documented."),
        bullet("Follow-up visits at 3, 6, 12, and 24 months post-operatively."),
        divider(),

        // ── SECTION 8: OUTCOME MEASURES ─────────────────────────────────────
        h1("8. Outcome Measures"),
        h2("8.1 Primary Outcome"),
        bullet("Edinburgh Visual Gait Score (EVGS) - validated observational gait scoring tool (score 0-44, lower = better)"),
        blank(),
        h2("8.2 Secondary Outcomes"),
        h3("Clinical Assessment"),
        bullet("GMFCS Level (I to V)"),
        bullet("Gross Motor Function Measure (GMFM-66 or GMFM-88)"),
        bullet("Functional Mobility Scale (FMS) - at 5m, 50m, 500m"),
        bullet("Modified Ashworth Scale (MAS) for spasticity (0-4)"),
        bullet("Joint Range of Motion (goniometry): hip, knee, ankle"),
        bullet("Muscle strength (MRC grade 0-5)"),
        bullet("Popliteal angle (indicator of hamstring tightness)"),
        bullet("Foot Progression Angle (intoeing/outoeing)"),
        blank(),
        h3("Gait-Specific Measures"),
        bullet("Observational gait analysis (video-based, 2 planes)"),
        bullet("Temporal-spatial parameters: cadence, step length, walking speed (if 3D gait lab available)"),
        bullet("Kinematics: hip, knee, ankle joint angles in sagittal plane (if 3D gait lab available)"),
        blank(),
        h3("Radiological Outcomes"),
        bullet("Femoral anteversion (CT-based or clinical estimate)"),
        bullet("Neck-shaft angle"),
        bullet("Tibial torsion"),
        bullet("Hip migration percentage (Reimer's index) for hip cases"),
        blank(),
        h3("Patient-Reported / Proxy-Reported Outcomes"),
        bullet("Pain Visual Analogue Scale (VAS) 0-10"),
        bullet("Caregiver satisfaction (5-point Likert scale)"),
        blank(),
        h2("8.3 Safety Outcomes"),
        bullet("Surgical complications (infection, non-union, neurovascular injury, re-fracture)"),
        bullet("30-day readmission rate"),
        bullet("Gait deterioration at any follow-up compared to baseline"),
        divider(),

        // ── SECTION 9: ASSESSMENT SCHEDULE ──────────────────────────────────
        h1("9. Assessment Schedule"),
        blank(),
        scheduleTable(),
        blank(),
        body("* 3D Gait Analysis - to be performed only if motion capture laboratory facilities are accessible; otherwise observational gait analysis (EVGS) will be the primary gait measure."),
        divider(),

        // ── SECTION 10: DATA COLLECTION ─────────────────────────────────────
        h1("10. Data Collection and Management"),
        h2("10.1 Data Collection Tools"),
        bullet("Structured Case Record Form (CRF) - to be maintained for each patient"),
        bullet("Video recording of gait (pre- and post-operative) using a standard camera, two planes (sagittal and coronal)"),
        bullet("Digital goniometer for ROM measurements"),
        bullet("Standardised photography for foot progression angle documentation"),
        bullet("Radiograph archiving via PACS/physical film"),
        blank(),
        h2("10.2 Data Entry and Storage"),
        bullet("All data will be entered into a password-protected Microsoft Excel / SPSS spreadsheet."),
        bullet("Paper CRFs will be stored in a locked cabinet in the department."),
        bullet("Data will be anonymised for analysis; patient identifiers will be maintained in a separate log."),
        bullet("Video recordings will be stored on an encrypted departmental hard drive."),
        bullet("Data will be retained for a minimum of 5 years post-study completion."),
        blank(),
        h2("10.3 Quality Control"),
        bullet("All gait assessments will be performed by the same trained observer to minimise inter-observer variability."),
        bullet("EVGS scoring will be performed by two independent observers for 20% of assessments to check inter-rater reliability."),
        bullet("Any missing data will be documented and handled using appropriate statistical methods (last observation carried forward / multiple imputation)."),
        divider(),

        // ── SECTION 11: STATISTICAL ANALYSIS ────────────────────────────────
        h1("11. Statistical Analysis"),
        h2("11.1 Descriptive Statistics"),
        bullet("Continuous variables: Mean +/- SD (if normally distributed) or Median (IQR) (if non-normal)"),
        bullet("Categorical variables: Frequency and percentage"),
        bullet("Distribution normality: Shapiro-Wilk test"),
        blank(),
        h2("11.2 Inferential Statistics"),
        bullet("Comparison of pre- vs. post-operative outcomes: Paired t-test (parametric) or Wilcoxon signed-rank test (non-parametric)"),
        bullet("Repeated measures analysis (3, 6, 12, 24 months): Repeated-measures ANOVA or Friedman test"),
        bullet("Subgroup comparisons (diplegia vs. hemiplegia; soft tissue vs. bony surgery): Independent t-test or Mann-Whitney U test"),
        bullet("Correlation analysis: Pearson / Spearman's rho"),
        bullet("All tests will be two-tailed; significance level p < 0.05"),
        blank(),
        h2("11.3 Software"),
        bullet("SPSS version 26 or later (IBM Corp.) OR R statistical software (free, open-source)"),
        divider(),

        // ── SECTION 12: ETHICAL CONSIDERATIONS ──────────────────────────────
        h1("12. Ethical Considerations"),
        bullet("Ethics approval will be obtained from the Institutional Ethics Committee (IEC), GGSMCH Faridkot, prior to enrolment of any participant."),
        bullet("The study will be conducted in accordance with the Declaration of Helsinki (2013 revision) and ICMR National Ethical Guidelines for Biomedical Research (2017)."),
        bullet("The study will be registered with the Clinical Trials Registry - India (CTRI) prior to enrolment."),
        bullet("Written informed consent will be obtained from parents/guardians. Patient assent will be sought for children aged 7 years and above."),
        bullet("Participation is voluntary; withdrawal at any time will not affect clinical care."),
        bullet("No experimental or additional procedures beyond standard clinical care will be performed. All investigations are as per routine surgical workup."),
        bullet("Data will be kept strictly confidential and no identifiable patient information will be disclosed in publications."),
        divider(),

        // ── SECTION 13: TIMELINE ─────────────────────────────────────────────
        h1("13. Study Timeline"),
        blank(),
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            right: { style: BorderStyle.SINGLE, size: 4, color: "1F497D" },
            insideH: { style: BorderStyle.SINGLE, size: 2, color: "B0B0B0" },
            insideV: { style: BorderStyle.SINGLE, size: 2, color: "B0B0B0" },
          },
          rows: [
            new TableRow({
              tableHeader: true,
              children: ["Phase", "Activity", "Duration"].map(h =>
                new TableCell({
                  shading: { type: ShadingType.CLEAR, color: "auto", fill: "1F497D" },
                  children: [new Paragraph({ children: [new TextRun({ text: h, bold: true, size: 20, font: "Arial", color: "FFFFFF" })] })],
                })
              ),
            }),
            ...[
              ["Phase 1", "Protocol writing, IEC approval, CTRI registration, CRF design", "Months 1-3"],
              ["Phase 2", "Pilot testing (5 patients), refining data collection tools", "Month 3-4"],
              ["Phase 3", "Patient enrolment and pre-operative assessment", "Months 4-28"],
              ["Phase 4", "Surgery (as per routine clinical schedule)", "Months 5-28"],
              ["Phase 5", "Post-operative follow-up (3, 6, 12 months)", "Months 8-30"],
              ["Phase 6", "Data cleaning, statistical analysis", "Months 29-32"],
              ["Phase 7", "Thesis writing, submission, and viva", "Months 33-36"],
            ].map(([phase, activity, duration], ri) =>
              new TableRow({
                children: [phase, activity, duration].map(cell =>
                  new TableCell({
                    shading: ri % 2 === 0
                      ? { type: ShadingType.CLEAR, color: "auto", fill: "F5F9FD" }
                      : { type: ShadingType.CLEAR, color: "auto", fill: "FFFFFF" },
                    children: [new Paragraph({ children: [new TextRun({ text: cell, size: 20, font: "Arial" })] })],
                  })
                ),
              })
            ),
          ],
        }),
        divider(),

        // ── SECTION 14: REFERENCES ───────────────────────────────────────────
        h1("14. Key References"),
        new Paragraph({
          children: [new TextRun({ text: "1. Amirmudin NA, Lavelle G, Theologis T, Thompson N, Ryan JM. Multilevel Surgery for Children With Cerebral Palsy: A Meta-analysis. Pediatrics. 2019;143(4):e20183390. PMID: 30918016.", size: 20, font: "Arial" })],
          spacing: { before: 60, after: 60 },
          indent: { left: 360, hanging: 360 },
        }),
        new Paragraph({
          children: [new TextRun({ text: "2. Campbell R, Tipping N, Carty C, Walsh J, Johnson L. Orthopaedic management of knee joint impairment in cerebral palsy: A systematic review and meta-analysis. Gait Posture. 2020;81:232-244. PMID: 32615408.", size: 20, font: "Arial" })],
          spacing: { before: 60, after: 60 },
          indent: { left: 360, hanging: 360 },
        }),
        new Paragraph({
          children: [new TextRun({ text: "3. Josse A, Pons C, Printemps C, et al. Rectus femoris surgery for the correction of stiff knee gait in cerebral palsy: A systematic review and meta-analysis. Orthop Traumatol Surg Res. 2023;109(3):103022. PMID: 34314902.", size: 20, font: "Arial" })],
          spacing: { before: 60, after: 60 },
          indent: { left: 360, hanging: 360 },
        }),
        new Paragraph({
          children: [new TextRun({ text: "4. Barik S, Chaudhary S, Kumar V, Raj V, Singh V. A systematic review and meta-analysis of long-term outcomes of femoral derotation surgery for intoeing gait in cerebral palsy. Gait Posture. 2024;112:1-8. PMID: 38718437.", size: 20, font: "Arial" })],
          spacing: { before: 60, after: 60 },
          indent: { left: 360, hanging: 360 },
        }),
        new Paragraph({
          children: [new TextRun({ text: "5. Langerak NG, Vaughan CL, Fieggen AG, et al. A prospective gait follow-up study 30 years after selective dorsal rhizotomy. J Neurosurg Pediatr. 2025. PMID: 40540792.", size: 20, font: "Arial" })],
          spacing: { before: 60, after: 60 },
          indent: { left: 360, hanging: 360 },
        }),
        divider(),

        // ── SECTION 15: SIGNATURES ───────────────────────────────────────────
        h1("15. Approval and Signatures"),
        blank(),
        infoTable([
          ["Principal Investigator", "Name: ________________________\nSignature: ____________________\nDate: _________________________"],
          ["Thesis Guide / Supervisor", "Name: ________________________\nDesignation: __________________\nSignature: ____________________\nDate: _________________________"],
          ["Head of Department", "Name: ________________________\nSignature: ____________________\nDate: _________________________"],
          ["IEC Chairperson", "Name: ________________________\nSignature: ____________________\nDate: _________________________"],
          ["IEC Approval Number", "[To be filled after approval]"],
          ["Date of IEC Approval", "[To be filled after approval]"],
        ]),
        blank(),
        blank(),

      ],
    },
  ],
});

Packer.toBuffer(doc).then(buffer => {
  fs.writeFileSync('/home/daytona/workspace/cp-thesis/CP_Gait_Study_Protocol_GGSMCH.docx', buffer);
  console.log("Document created successfully.");
}).catch(err => {
  console.error("Error:", err);
  process.exit(1);
});

cd /home/daytona/workspace/cp-thesis && node generate_protocol.js

python3 /home/daytona/skills/docx/scripts/office/validate.py /home/daytona/works…

python3 -c "import zipfile; z = zipfile.ZipFile('/home/daytona/workspace/cp-thes…

ls -lh /home/daytona/workspace/cp-thesis/