NCT07683338

Brief Summary

Cerebral palsy is a neurological condition that affects movement, muscle control, and walking ability in children. Children with bilateral spastic cerebral palsy often experience increased muscle stiffness, difficulty with walking, reduced balance, and limited functional mobility. This randomized controlled trial aims to evaluate whether treadmill gait training combined with conventional physiotherapy can improve walking ability, gross motor function, balance, and mobility compared with conventional physiotherapy alone. Children with bilateral spastic cerebral palsy will receive a 12-week rehabilitation program, and changes in motor function, gait performance, spasticity, and walking endurance will be assessed before and after treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Completed
Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

June 27, 2026

Last Update Submit

July 21, 2026

Conditions

Bilateral Spastic Cerebral PalsyCerebral PalsySpasticity Due to Cerebral PalsyGait AbnormalityMmotor Function Impairment

Keywords

Cerebral PalsyTreadmill TrainingGait TrainingNeurorehabilitationGross Motor Function

Outcome Measures

Primary Outcomes (1)

  • Change in Gross Motor Function Measure-66 (GMFM-66) Score

    The Gross Motor Function Measure-66 (GMFM-66) is a standardized and validated observational assessment used to evaluate changes in gross motor function in children with cerebral palsy. This study will assess changes in the Standing (Dimension D) and Walking, Running, and Jumping (Dimension E) domains to evaluate improvements in functional mobility and gait-related abilities.

    Baseline and Week 12

Secondary Outcomes (6)

  • MAS

    Baseline and Week 12

  • Change in 10 Meter Walk Test (10MWT) Walking Velocity

    Baseline and Week 12

  • Change in Timed Up and Go Test (TUG) Performance

    Baseline and Week 12

  • Change in Pediatric Balance Scale (PBS) Score

    Baseline and Week 12

  • Change in Modified Ashworth Scale (MAS) Score

    Baseline and Week 12

  • +1 more secondary outcomes

Other Outcomes (1)

  • MAS

    Baseline and Week 12

Study Arms (2)

Treadmill Gait Training + Conventional Physiotherapy

EXPERIMENTAL

Participants will receive treadmill gait training combined with conventional physiotherapy for 12 weeks. Treadmill training will be provided for 30 minutes per session, 3 sessions per week (total 36 sessions). Treadmill speed, assistance level, and progression will be individually adjusted according to participant tolerance, gait quality, and safety. Sessions will be supervised by a qualified physiotherapist. The conventional physiotherapy program will include stretching exercises, strengthening exercises, balance training, and functional task-oriented activities including sit-to-stand practice, stair training, and obstacle negotiation.

Other: Treadmill Gait TrainingOther: Conventional Physiotherapy

Conventional Physiotherapy

ACTIVE COMPARATOR

Participants will receive conventional physiotherapy for 12 weeks, 3 sessions per week. The rehabilitation program will include stretching exercises, strengthening exercises, balance training, and functional task-oriented activities. The intervention will follow the same duration and frequency as the experimental group but without treadmill gait training.

Other: Conventional Physiotherapy

Interventions

Conventional PhysiotherapyOTHER

A rehabilitation program including stretching, strengthening, balance training, and functional activities aimed at improving mobility and motor function in children with bilateral spastic cerebral palsy.

Conventional PhysiotherapyTreadmill Gait Training + Conventional Physiotherapy
Treadmill Gait TrainingOTHER

A task-specific locomotor training intervention involving treadmill walking practice for 30 minutes per session, 3 sessions per week for 12 weeks, combined with conventional physiotherapy.

Treadmill Gait Training + Conventional Physiotherapy

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinically confirmed diagnosis of bilateral spastic cerebral palsy.
  • Aged 6 to 16 years.
  • Classified as GMFCS Levels I-III.
  • Able to stand independently, with or without support.
  • Presence of clinically significant lower-limb spasticity, defined as Modified Ashworth Scale (MAS) score ≥2.
  • Demonstrated ambulatory ability with Timed Up and Go (TUG) ≤10 seconds.
  • Demonstrated walking ability with 6-Minute Walk Test (6MWT) distance of 50-500 meters at baseline.
  • Able to understand simple verbal commands and participate in structured therapy sessions.
  • Parent or legal guardian willing to provide written informed consent.

You may not qualify if:

  • Botulinum toxin injection within the previous 6 months.
  • Recent pharmacological intervention significantly affecting spasticity.
  • Lower-limb orthopedic surgery within the previous 12 months.
  • Severe intellectual disability (IQ \<70) or inability to follow simple instructions required for therapy participation.
  • Uncontrolled seizures, epilepsy, or other neurological conditions that could interfere with participation.
  • Fixed musculoskeletal contractures limiting standing, stepping, or gait training.
  • Cardiopulmonary, medical, or orthopedic conditions that contraindicate treadmill-based exercise.
  • Current participation in another gait-training or rehabilitation research study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syeda Khatoon e Jannat Trust Hospital & Special Education Centre

Faisalabad, Punjab Province, 3800, Pakistan

Location

Related Publications (5)

  • Alotaibi A, Ibrahim A, Ahmed R, Abualait T. Effectiveness of Partial Body Weight-Supported Treadmill Training on Various Outcomes in Different Contexts among Children and Adolescents with Cerebral Palsy: A Systematic Review and Meta-Analysis. Children (Basel). 2023 Dec 20;11(1):9. doi: 10.3390/children11010009.

    PMID: 38275430BACKGROUND

  • Chen Y, Li X, Wang L, et al. Effects of neuromuscular and physical therapy interventions on lower limb spasticity and gait performance in children with cerebral palsy: systematic review and meta-analysis. Front Pediatr. 2023;11:1185672.

    BACKGROUND

  • Desloovere K, Molenaers G, Feys H, et al. Evidence-based interventions for improving gait function in children with cerebral palsy: clinical perspectives and rehabilitation approaches. Dev Med Child Neurol. 2021;63(5):567-575.

    BACKGROUND

  • Liang X, Tan Z, Yun G, Cao J, Wang J, Liu Q, Chen T. Effectiveness of exercise interventions for children with cerebral palsy: A systematic review and meta-analysis of randomized controlled trials. J Rehabil Med. 2021 Apr 1;53(4):jrm00176. doi: 10.2340/16501977-2772.

    PMID: 33225375BACKGROUND

  • Han YG, Yun CK. Effectiveness of treadmill training on gait function in children with cerebral palsy: meta-analysis. J Exerc Rehabil. 2020 Feb 26;16(1):10-19. doi: 10.12965/jer.1938748.374. eCollection 2020 Feb.

    PMID: 32161730BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyMobility Limitation

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dr. Tehreem Jameel, DPT; PGD-PPT

    Syeda Khatoon e Jannat Trust Hospital & Special Education Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will be blinded to group allocation to reduce measurement bias. Participants and care providers will not be blinded due to the nature of the rehabilitation intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly allocated into two parallel groups: treadmill gait training combined with conventional physiotherapy and conventional physiotherapy alone.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and Clinical Research Coordinator

Study Record Dates

First Submitted

June 27, 2026

First Posted

July 6, 2026

Study Start

February 1, 2026

Primary Completion

April 30, 2026

Study Completion

July 15, 2026

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with other researchers due to ethical considerations, participant confidentiality, and data protection requirements. The collected data will be used solely for the purposes specified in this study protocol. De-identified aggregated results will be reported in scientific publications and presentations to contribute to evidence-based rehabilitation practice.

Locations

PA(1)