- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06463301
Effects of Treadmill Training on Motor Function, Balance, and Spasticity Reduction in Children With Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
KP
-
Peshawar, KP, Pakistan, 18800
- Helping Hand Rehabilitation center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 4 -12 years.
- Children having, I-II on GMFCM.
- Children diagnosed with spastic cerebral palsy.
- Children with will cognitive behavior
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treadmill Training in cp child
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 |
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. |
|
Active Comparator: Conventional Physical therapy
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
12th weeks study , 1st reading will be take on baseline than after 4 weeks ,8weeks & 12weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Ashworth Scale to measure spasticity
Time Frame: 12th weeks study , 1st reading will be take on baseline than after 4 weeks ,8weeks & 12weeks
|
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
|
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
|
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 |
12th weeks study ,1st reading will be take on baseline than after 4 weeks ,8weeks & 12weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Waqar Ahmad Awan, Phd, Riphah International University
- Principal Investigator: Numan Sadiq, MS SPT, Riphah International University
Publications and helpful links
General Publications
- Mattern-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.
- 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.
- Chrysagis 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.
- Mutlu 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. Erratum In: Dev Med Child Neurol. 2009 Sep;51(9):761.
- Mattern-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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIPHAH/FR&AHS-01827
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Ankara City Hospital BilkentRecruitingCerebral Palsy (CP) | Cerebral Palsy, Spastic, Diplegic | Diplegic Cerebral Palsy With Spasticity | Transcranial Magnetic StimilationTurkey (Türkiye)
-
Lahore University of Biological and Applied SciencesRecruiting
-
Suleyman Demirel UniversityCompletedCerebral Palsy | Hemiplegic Cerebral Palsy | Spastic Diplegia Cerebral PalsyTurkey (Türkiye)
-
Holland Bloorview Kids Rehabilitation HospitalCanadian Institutes of Health Research (CIHR)RecruitingCerebral Palsy (CP) | Hemiplegic Cerebral PalsyCanada
-
Cairo UniversityCompletedCerebral Palsy (CP) | Unilateral Cerebral PalsyEgypt
-
University of California, San FranciscoNot yet recruitingCerebral Palsy | Cerebral Palsy (CP) | Infant | Cerebral Palsy InfantileUnited States
-
Lahore University of Biological and Applied SciencesNot yet recruitingSpastic Diplegia Cerebral PalsyPakistan
-
IRCCS Fondazione Stella MarisUniversity of Siena, ItalyRecruitingCerebral Palsy (CP) | Motor Imagery | CP (Cerebral Palsy) | Action ObservationItaly
-
IRCCS Fondazione Stella MarisNot yet recruitingCerebral Palsy (CP) | EEG | Unilateral Cerebral Palsy | Action ObservationItaly
-
University of LahoreCompletedCerebral Palsy (CP) | Spastic Diplegia Cerebral Palsy | Balance | Gross Motor FunctionsPakistan
Clinical Trials on Treadmill Training In CP child
-
Memorial University of NewfoundlandCompletedMultiple Sclerosis | Rehabilitation | Gait Disorders, Neurologic | Neuronal PlasticityCanada
-
Fondation Ellen PoidatzRecruitingCerebral Palsy | Gait Disorders, NeurologicFrance
-
Somogy Megyei Kaposi Mór Teaching HospitalRecruiting
-
Marquette UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingMultiple SclerosisUnited States
-
Riphah International UniversityCompleted
-
Universita di VeronaUnknown
-
National Yang Ming UniversityCompletedStroke | Cognitive ImpairmentTaiwan
-
Fondazione Don Carlo Gnocchi OnlusUnknownStroke | Multiple Sclerosis | Parkinson DiseaseItaly
-
University of Kansas Medical CenterNot yet recruitingMotoric Cognitive Risk SyndromeUnited States