Cerebral PalsyNCT06463301
Effects of Treadmill Training on Motor Function, Balance, and Spasticity Reduction in Children With Cerebral Palsy
A study testing Treadmill Training In CP child and Conventional Physical Therapy in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study investigates the impact of treadmill training on motor function, balance, and spasticity reduction in children with cerebral palsy (CP). The study synthesizes existing research to provide insights into the effectiveness of treadmill training as an intervention for improving these key outcomes in children… Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Treadmill Training In CP child and Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Apr 2024to 15 Jan 2025
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 4 -12 years.
- Children having, I-II on GMFCM.
- Children diagnosed with spastic cerebral palsy.
- Children with will cognitive behavior
Who cannot join
- Misdiagnosed or not conform to Cerebral palsy.
- Children should be medically un stable uncontrolled seizures
- The children with mental retardation or other neurological disorders.
- Children with serve respiratory dysfunction, multiple contracture.
- Children with prior undone this type of training.
- Children with taking medication like muscle relaxant.
- Children having communication or hearing issues.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Helping Hand Rehabilitation center
Peshawar, Khyber Pakhtunkhwa, 18800
About this study
This study investigates the impact of treadmill training on motor function, balance, and spasticity reduction in children with cerebral palsy (CP). The study synthesizes existing research to provide insights into the effectiveness of treadmill training as an intervention for improving these key outcomes in children with Cerebral palsy
Read the detailed description
Cerebral palsy is a neurodevelopmental disorder characterized by impaired movement and posture due to non-progressive brain damage occurring before, during, or shortly after birth.this systematic review and meta-analysis comprehensively examines the effects of treadmill training on motor function, balance, and spasticity reduction in children diagnosed with cerebral palsy (CP).
The review includes studies published in peer-reviewed journals, databases, and relevant conference proceedings. Inclusion criteria encompass randomized controlled trials, quasi-experimental studies, and cohort studies evaluating treadmill training interventions in children aged 2-18 years with CP. Studies utilizing various treadmill training protocols, such as body-weight-supported treadmill training, overground treadmill training, or virtual reality-assisted treadmill training, are considered.
The primary outcomes assessed include changes in motor function, as measured by standardized assessment tools like the Gross Motor Function Measure (GMFM) or the Movement Assessment Battery for Children (MABC). Additionally, balance improvements are evaluated using validated balance assessment scales, while spasticity reduction is measured through clinical assessments, such as the Modified Ashworth Scale (MAS) or the Tardieu Scale.
The review aims to provide evidence-based insights into the efficacy of treadmill training as a rehabilitation intervention for children with CP, informing clinical practice guidelines and therapeutic decision-making. The findings contribute to our understanding of the potential benefits of treadmill training in improving motor function, balance, and spasticity in this
- Conditions
- Cerebral Palsy
- Being tested
- Treadmill Training In CP child, Conventional Physical Therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill Training In CP childOther
Treadmill training for children should be carefully tailored to their developmental level, physical ability, and specific therapeutic goals. Initial Sessions start with shorter sessions, around 5-10 minutes, especially for children with disabilities.
Progression will be made when the child becomes more accustomed to the treadmill. Aim for a total of 20-30 minutes per session, including breaks if necessary then then Start at a slow walking pace, approximately 0.5 to 1.0 miles per hour (mph) or 0.8 to 1.6 kilometers per hour (kph). Adjust the speed based on the child's comfort and ability to maintain a safe and effective walking pattern.
Older Children (8-12 years Begin with a walking pace of 1.0 to 1.5 mph (1.6 to 2.4 kph). Gradually increase the speed to a brisk walk or light jog, up to 2.0 to 3.0 mph (3.2 to 4.8 kph), depending on the child's progress and comfort level along with conventional physical therapy.
Conventional Physical TherapyOther
conventional physical therapy session would typically include gentle stretching, joint mobilization, range of motion exercises for both the upper and lower body, gait training, and standing frame activities. Each component is designed to improve various aspects of physical function, ensuring a comprehensive approach to rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Treadmill Training in cp child | Experimental | Treadmill training for children should be carefully tailored to their developmental level, physical ability, and specific therapeutic goals. Initial Sessions start with shorter sessions, around 5-10 minutes, especially for children with disabilities.
Progression will be made when the child becomes more accustomed to the treadmill. Aim for a total of 20-30 minutes per session, including breaks if necessary then then Start at a slow walking pace, approximately 0.5 to 1.0 miles per hour (mph) or 0.8 to 1.6 kilometers per hour (kph). Adjust the speed based on the child's comfort and ability to maintain a safe and effective walking pattern.
Older Children (8-12 years Begin with a walking pace of 1.0 to 1.5 mph (1.6 to 2.4 kph). Gradually increase the speed to a brisk walk or light jog, up to 2.0 to 3.0 mph (3.2 to 4.8 kph), depending on the child's progress and comfort level along with conventional physical therapy Receives: Other: Treadmill Training In CP child |
| Conventional Physical therapy | Active comparator | conventional physical therapy session would typically include gentle stretching, joint mobilization, range of motion exercises for both the upper and lower body, gait training, and standing frame activities. Each component is designed to improve various aspects of physical function, ensuring a comprehensive approach to rehabilitation Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Balance scale to Measure balance
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (the lowest function) to 4 points (the highest function), with a maximum score of 56 points.in his study, we assessed the effect of treadmill training on balance of CP child
Measured: 12th weeks study , 1st reading will be take on baseline than after 4 weeks ,8weeks & 12weeks
Secondary outcomes (2)
Modified Ashworth Scale to measure spasticity
Ashworth Scale measures spasticity in patients with lesions to the central nervous system. AS is an assessment that is used to measure the increase in muscle tone. AS assigns a grade of spasticity from a 0-4 ordinal scale 0 means no spasticity 4 means complete rigidity
Measured: 12th weeks study , 1st reading will be take on baseline than after 4 weeks ,8weeks & 12weeks
GMFCS (Gross Motor Function Classification System) to measure the motor functions
The GMFCS, or Gross Motor Function Classification System, is a five-level classification that differentiates children with cerebral palsy based on the child's current gross motor abilities, limitations in gross motor function, and need for assistive technology and wheeled mobility.
total score is 5 5 full dependent
1 is independent of the limitation
Measured: 12th weeks study ,1st reading will be take on baseline than after 4 weeks ,8weeks & 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start28 Apr 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
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 Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Waqar Ahmad Awan, Phd, Principal investigator, Riphah International UniversityNuman Sadiq, MS SPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463301
- Sponsor's protocol ID
- RIPHAH/FR&AHS-01827
- Status last verified
- Jun 2025
- First submitted
- 29 Apr 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grecco LA, Zanon N, Sampaio LM, Oliveira CS. A comparison of treadmill training and overground walking in ambulant children with cerebral palsy: randomized controlled clinical trial. Clin Rehabil. 2013 Aug;27(8):686-96. doi: 10.1177/0269215513476721. Epub 2013 Mar 15.
PubMed 23503736Chrysagis N, Skordilis EK, Stavrou N, Grammatopoulou E, Koutsouki D. The effect of treadmill training on gross motor function and walking speed in ambulatory adolescents with cerebral palsy: a randomized controlled trial. Am J Phys Med Rehabil. 2012 Sep;91(9):747-60. doi: 10.1097/PHM.0b013e3182643eba.
PubMed 22902937Mutlu A, Krosschell K, Spira DG. Treadmill training with partial body-weight support in children with cerebral palsy: a systematic review. Dev Med Child Neurol. 2009 Apr;51(4):268-75. doi: 10.1111/j.1469-8749.2008.03221.x. Epub 2009 Jan 21.
PubMed 19207302Mattern-Baxter K. Effects of partial body weight supported treadmill training on children with cerebral palsy. Pediatr Phys Ther. 2009 Spring;21(1):12-22. doi: 10.1097/PEP.0b013e318196ef42.
PubMed 19214072Mattern-Baxter K, Bellamy S, Mansoor JK. Effects of intensive locomotor treadmill training on young children with cerebral palsy. Pediatr Phys Ther. 2009 Winter;21(4):308-18. doi: 10.1097/PEP.0b013e3181bf53d9.
PubMed 19923970
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treadmill Training on Motor Function, Balance, and Spasticity Reduction in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06463301
- Acronym / sponsor ID
- RIPHAH/FR&AHS-01827
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Apr 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 17 Jun 2024 (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.
This study investigates the impact of treadmill training on motor function, balance, and spasticity reduction in children with cerebral palsy (CP). The study synthesizes existing research to provide insights into the effectiveness of treadmill training as an intervention for improving these key outcomes in children with Cerebral palsy
Detailed description
Cerebral palsy is a neurodevelopmental disorder characterized by impaired movement and posture due to non-progressive brain damage occurring before, during, or shortly after birth.this systematic review and meta-analysis comprehensively examines the effects of treadmill training on motor function, balance, and spasticity reduction in children diagnosed with cerebral palsy (CP).
The review includes studies published in peer-reviewed journals, databases, and relevant conference proceedings. Inclusion criteria encompass randomized controlled trials, quasi-experimental studies, and cohort studies evaluating treadmill training interventions in children aged 2-18 years with CP. Studies utilizing various treadmill training protocols, such as body-weight-supported treadmill training, overground treadmill training, or virtual reality-assisted treadmill training, are considered.
The primary outcomes assessed include changes in motor function, as measured by standardized assessment tools like the Gross Motor Function Measure (GMFM) or the Movement Assessment Battery for Children (MABC). Additionally, balance improvements are evaluated using validated balance assessment scales, while spasticity reduction is measured through clinical assessments, such as the Modified Ashworth Scale (MAS) or the Tardieu Scale.
The review aims to provide evidence-based insights into the efficacy of treadmill training as a rehabilitation intervention for children with CP, informing clinical practice guidelines and therapeutic decision-making. The findings contribute to our understanding of the potential benefits of treadmill training in improving motor function, balance, and spasticity in this
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill Training in cp child | Experimental | Other: Treadmill Training In CP childTreadmill training for children should be carefully tailored to their developmental level, physical ability, and specific therapeutic goals. Initial Sessions start with shorter sessions, around 5-10 minutes, especially for children with disabilities. Progression will be made when the child becomes more accustomed to the treadmill. Aim for a total of 20-30 minutes per session, including breaks if necessary then then Start at a slow walking pace, approximately 0.5 to 1.0 miles per hour (mph) or 0.8 to 1.6 kilometers per hour (kph). Adjust the speed based on the child's comfort and ability to maintain a safe and effective walking pattern. Older Children (8-12 years Begin with a walking pace of 1.0 to 1.5 mph (1.6 to 2.4 kph). Gradually increase the speed to a brisk walk or light jog, up to 2.0 to 3.0 mph (3.2 to 4.8 kph), depending on the child's progress and comfort level along with conventional physical therapy |
| Conventional Physical therapy | Active comparator | Other: Conventional Physical Therapyconventional physical therapy session would typically include gentle stretching, joint mobilization, range of motion exercises for both the upper and lower body, gait training, and standing frame activities. Each component is designed to improve various aspects of physical function, ensuring a comprehensive approach to rehabilitation |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 4 -12 years.
- Children having, I-II on GMFCM.
- Children diagnosed with spastic cerebral palsy.
- Children with will cognitive behavior
Key exclusion criteria (7 listed)
- Misdiagnosed or not conform to Cerebral palsy.
- Children should be medically un stable uncontrolled seizures
- The children with mental retardation or other neurological disorders.
- Children with serve respiratory dysfunction, multiple contracture.
- Children with prior undone this type of training.
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 Training In CP childTreadmill training for children should be carefully tailored to their developmental level, physical ability, and specific therapeutic goals. Initial Sessions start with shorter sessions, around 5-10 minutes, especially for children with disabilities. Progression will be made when the child becomes more accustomed to the treadmill. Aim for a total of 20-30 minutes per session, including breaks if necessary then then Start at a slow walking pace, approximately 0.5 to 1.0 miles per hour (mph) or 0.8 to 1.6 kilometers per hour (kph). Adjust the speed based on the child's comfort and ability to maintain a safe and effective walking pattern. Older Children (8-12 years Begin with a walking pace of 1.0 to 1.5 mph (1.6 to 2.4 kph). Gradually increase the speed to a brisk walk or light jog, up to 2.0 to 3.0 mph (3.2 to 4.8 kph), depending on the child's progress and comfort level along with conventional physical therapy. | Other | Treadmill Training in cp child |
| Conventional Physical Therapyconventional physical therapy session would typically include gentle stretching, joint mobilization, range of motion exercises for both the upper and lower body, gait training, and standing frame activities. Each component is designed to improve various aspects of physical function, ensuring a comprehensive approach to rehabilitation | Other | Conventional Physical therapy |
Primary outcome
Pediatric Balance scale to Measure balance
Time frame: 12th weeks study , 1st reading will be take on baseline than after 4 weeks ,8weeks & 12weeks
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (the lowest function) to 4 points (the highest function), with a maximum score of 56 points.in his study, we assessed the effect of treadmill training on balance of CP child
2 secondary outcomes
Modified Ashworth Scale to measure spasticity
Time frame: 12th weeks study , 1st reading will be take on baseline than after 4 weeks ,8weeks & 12weeks
GMFCS (Gross Motor Function Classification System) to measure the motor functions
Time frame: 12th weeks study ,1st reading will be take on baseline than after 4 weeks ,8weeks & 12weeks
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 15 Jun 2025.
- Background: PubMed 23503736Grecco LA, Zanon N, Sampaio LM, Oliveira CS. A comparison of treadmill training and overground walking in ambulant children with cerebral palsy: randomized controlled clinical trial. Clin Rehabil. 2013 Aug;27(8):686-96. doi: 10.1177/0269215513476721. Epub 2013 Mar 15.
- Background: PubMed 22902937Chrysagis N, Skordilis EK, Stavrou N, Grammatopoulou E, Koutsouki D. The effect of treadmill training on gross motor function and walking speed in ambulatory adolescents with cerebral palsy: a randomized controlled trial. Am J Phys Med Rehabil. 2012 Sep;91(9):747-60. doi: 10.1097/PHM.0b013e3182643eba.
- Background: PubMed 19207302Mutlu A, Krosschell K, Spira DG. Treadmill training with partial body-weight support in children with cerebral palsy: a systematic review. Dev Med Child Neurol. 2009 Apr;51(4):268-75. doi: 10.1111/j.1469-8749.2008.03221.x. Epub 2009 Jan 21.
- Background: PubMed 19214072Mattern-Baxter K. Effects of partial body weight supported treadmill training on children with cerebral palsy. Pediatr Phys Ther. 2009 Spring;21(1):12-22. doi: 10.1097/PEP.0b013e318196ef42.
- Background: PubMed 19923970Mattern-Baxter K, Bellamy S, Mansoor JK. Effects of intensive locomotor treadmill training on young children with cerebral palsy. Pediatr Phys Ther. 2009 Winter;21(4):308-18. doi: 10.1097/PEP.0b013e3181bf53d9.
- Individual participant dataSharing planned: No
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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.
Waqar Ahmad Awan, Phd principal investigator
Riphah International University
Numan Sadiq, MS SPT principal investigator
Riphah International University
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 Training In CP child and Conventional Physical Therapy in people with Cerebral Palsy, run by Riphah International University 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 4 inclusion and 7 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 15 Jun 2025. 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?
Pediatric Balance scale to Measure balance (time frame: 12th weeks study , 1st reading will be take on baseline than after 4 weeks ,8weeks & 12weeks). 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 NCT06463301, 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 15 Jun 2025.