NCT06463301

Brief 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 with Cerebral palsy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

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

April 28, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 29, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

9 months

First QC Date

April 29, 2024

Last Update Submit

June 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    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

    12th weeks study ,1st reading will be take on baseline than after 4 weeks ,8weeks & 12weeks

Study Arms (2)

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

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

Other: Conventional Physical Therapy

Interventions

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 in cp child

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

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 4 -12 years.
  • Children having, I-II on GMFCM.
  • Children diagnosed with spastic cerebral palsy.
  • Children with will cognitive behavior

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helping Hand Rehabilitation center

Peshawar, Khyber Pakhtunkhwa, 18800, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 23503736BACKGROUND
  • 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.

    PMID: 22902937BACKGROUND
  • 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.

    PMID: 19207302BACKGROUND
  • 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.

    PMID: 19214072BACKGROUND
  • 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.

    PMID: 19923970BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Waqar Ahmad Awan, Phd

    Riphah International University

    PRINCIPAL INVESTIGATOR
  • Numan Sadiq, MS SPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2024

First Posted

June 17, 2024

Study Start

April 28, 2024

Primary Completion

January 15, 2025

Study Completion

January 15, 2025

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations