Bilateral Spastic Cerebral PalsyGAIT-CPNCT07683338
Effect of Treadmill Gait Training Combined With Conventional Physiotherapy on Gait Performance and Functional Mobility in Children With Bilateral Spastic Cerebral Palsy: A Randomized Controlled Trial
A study testing Treadmill Gait Training and Conventional Physiotherapy in people with Bilateral Spastic Cerebral Palsy and Cerebral Palsy, run by Syeda Khatoon e Jannat Welfare Foundation at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Bilateral Spastic Cerebral Palsy, Cerebral Palsy, Spasticity Due to Cerebral Palsy
- What is being tested?
- Treadmill Gait Training and Conventional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2026to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Show all 18Show fewer
- 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.
- Willing and able to attend the complete 12-week intervention protocol. Exclusion Criteria
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Syeda Khatoon e Jannat Trust Hospital & Special Education Centre
Faisalabad, Punjab Province, 3800
About this study
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.
Read the detailed description
Bilateral spastic cerebral palsy (CP) is associated with lower-limb spasticity, impaired motor control, abnormal gait patterns, reduced walking speed, and limitations in functional mobility. Task-specific repetitive locomotor training is an important component of pediatric neurorehabilitation, and treadmill gait training may enhance stepping practice and improve gait-related outcomes.
This assessor-blinded, parallel-group randomized controlled trial aims to evaluate the effect of treadmill gait training combined with conventional physiotherapy compared with conventional physiotherapy alone in children with bilateral spastic CP. Children aged 6-16 years with GMFCS Level I-III will be recruited from Syeda Khatoon e Jannat Trust Hospital.
Participants will be randomly allocated into two groups. The intervention group will receive treadmill gait training (30 minutes/session, 3 sessions/week for 12 weeks) in addition to conventional physiotherapy, including stretching, strengthening, balance training, and functional activities. The control group will receive conventional physiotherapy alone.
Outcomes will be assessed at baseline and after intervention using the Gross Motor Function Measure (GMFM-66) as the primary outcome, along with the 10 Meter Walk Test, Timed Up and Go Test, Pediatric Balance Scale, Modified Ashworth Scale, and 6 Minute Walk Test to evaluate gait performance, functional mobility, balance, spasticity, and walking endurance.
- Conditions
- Bilateral Spastic Cerebral Palsy, Cerebral Palsy, Spasticity Due to Cerebral Palsy, Gait Abnormality, Mmotor Function Impairment
- Being tested
- Treadmill Gait Training, Conventional Physiotherapy
- Keywords
- Cerebral Palsy, Treadmill Training, Gait Training, Neurorehabilitation, Gross Motor Function
- Medical subject headings
- Cerebral Palsy, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Treadmill Gait Training; Other: 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. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 12
Secondary outcomes (6)
MAS
randomised controlled trial
Measured: Baseline and Week 12
Change in 10 Meter Walk Test (10MWT) Walking Velocity
The 10 Meter Walk Test measures walking speed over a 10-meter distance. Walking velocity (meters/second) will be assessed to determine changes in gait speed and locomotor efficiency following intervention.
Measured: Baseline and Week 12
Change in Timed Up and Go Test (TUG) Performance
The Timed Up and Go Test measures functional mobility and dynamic balance by recording the time required to stand from a chair, walk 3 meters, turn, return, and sit down.
Measured: Baseline and Week 12
Change in Pediatric Balance Scale (PBS) Score
The Pediatric Balance Scale is a 14-item performance-based measure used to assess functional balance abilities in children. Changes in balance performance will be evaluated following the intervention.
Measured: Baseline and Week 12
Change in Modified Ashworth Scale (MAS) Score
The Modified Ashworth Scale is an ordinal clinical scale used to assess changes in muscle spasticity. Lower-limb muscle groups including hip adductors, hamstrings, and gastrocnemius-soleus muscles will be evaluated.
Measured: Baseline and Week 12
Change in 6 Minute Walk Test (6MWT) Distance
The 6 Minute Walk Test measures walking endurance by recording the total distance walked in 6 minutes. It will be used to evaluate changes in functional walking capacity.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Feb 2026
- Primary completion30 Apr 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bilateral Spastic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated into two parallel groups: treadmill gait training combined with conventional physiotherapy and conventional physiotherapy alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syeda Khatoon e Jannat Welfare Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tehreem Jameel, Syeda Khatoon e Jannat Welfare Foundation
- Investigators
- Dr. Tehreem Jameel, DPT; PGD-PPT, Principal investigator, Syeda Khatoon e Jannat Trust Hospital & Special Education Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683338
- Sponsor's protocol ID
- 003-SKJWF-2026
- Acronym
- GAIT-CP
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38275430Chen 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.
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.
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.
PubMed 33225375Han 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.
PubMed 32161730
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treadmill Gait Training Combined With Conventional Physiotherapy on Gait Performance and Functional Mobility in Children With Bilateral Spastic Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07683338
- Acronym / sponsor ID
- GAIT-CP / 003-SKJWF-2026
- Conditions
- Bilateral Spastic Cerebral Palsy, Cerebral Palsy, Spasticity Due to Cerebral Palsy, Gait Abnormality, Mmotor Function Impairment
- Keywords
- Cerebral Palsy, Treadmill Training, Gait Training, Neurorehabilitation, Gross Motor Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Syeda Khatoon e Jannat Welfare FoundationUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Bilateral spastic cerebral palsy (CP) is associated with lower-limb spasticity, impaired motor control, abnormal gait patterns, reduced walking speed, and limitations in functional mobility. Task-specific repetitive locomotor training is an important component of pediatric neurorehabilitation, and treadmill gait training may enhance stepping practice and improve gait-related outcomes.
This assessor-blinded, parallel-group randomized controlled trial aims to evaluate the effect of treadmill gait training combined with conventional physiotherapy compared with conventional physiotherapy alone in children with bilateral spastic CP. Children aged 6-16 years with GMFCS Level I-III will be recruited from Syeda Khatoon e Jannat Trust Hospital.
Participants will be randomly allocated into two groups. The intervention group will receive treadmill gait training (30 minutes/session, 3 sessions/week for 12 weeks) in addition to conventional physiotherapy, including stretching, strengthening, balance training, and functional activities. The control group will receive conventional physiotherapy alone.
Outcomes will be assessed at baseline and after intervention using the Gross Motor Function Measure (GMFM-66) as the primary outcome, along with the 10 Meter Walk Test, Timed Up and Go Test, Pediatric Balance Scale, Modified Ashworth Scale, and 6 Minute Walk Test to evaluate gait performance, functional mobility, balance, spasticity, and walking endurance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated into two parallel groups: treadmill gait training combined with conventional physiotherapy and conventional physiotherapy alone.
| Arm | Type | Receives |
|---|---|---|
| Treadmill Gait Training + Conventional Physiotherapy | Experimental | Other: Treadmill Gait Training, Other: Conventional PhysiotherapyParticipants 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. |
| Conventional Physiotherapy | Active comparator | Other: Conventional PhysiotherapyParticipants 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. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill Gait TrainingA 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. | Other | Treadmill Gait Training + Conventional Physiotherapy |
| Conventional PhysiotherapyA rehabilitation program including stretching, strengthening, balance training, and functional activities aimed at improving mobility and motor function in children with bilateral spastic cerebral palsy. | Other | Conventional Physiotherapy, Treadmill Gait Training + Conventional Physiotherapy |
Primary outcome
Change in Gross Motor Function Measure-66 (GMFM-66) Score
Time frame: Baseline and Week 12
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.
6 secondary outcomes
MAS
Time frame: Baseline and Week 12
Change in 10 Meter Walk Test (10MWT) Walking Velocity
Time frame: Baseline and Week 12
Change in Timed Up and Go Test (TUG) Performance
Time frame: Baseline and Week 12
Change in Pediatric Balance Scale (PBS) Score
Time frame: Baseline and Week 12
Change in Modified Ashworth Scale (MAS) Score
Time frame: Baseline and Week 12
Change in 6 Minute Walk Test (6MWT) Distance
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 38275430Alotaibi 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.
- BackgroundChen 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.
- BackgroundDesloovere 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: PubMed 33225375Liang 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.
- Background: PubMed 32161730Han 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Tehreem Jameel, DPT; PGD-PPT principal investigator
Syeda Khatoon e Jannat Trust Hospital & Special Education Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill Gait Training and Conventional Physiotherapy in people with Bilateral Spastic Cerebral Palsy and Cerebral Palsy, run by Syeda Khatoon e Jannat Welfare Foundation at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gross Motor Function Measure-66 (GMFM-66) Score (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07683338, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.