Repetitive Split-Belt Treadmill Perturbation in Children With Unilateral Cerebral Palsy

NCT05350241 | Completed

• 1 other identifier: RHPT/0021/0017
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to investigate the effect of repeated split-belt treadmill waking practice on gait symmetry, dynamic balance control, and locomotor capacity in adolescents with unilateral cerebral palsy (ULCP). Fifty-two children with ULCP were randomly allocated to the split-belt treadmill walking (n = 26; undergone split-elt treadmill training or the Control group (n =23, received standard rehabilitation program). Both groups were assessed for gait symmetry, dynamic balance control, and locomotor capacity pre and post-treatment.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (3)

• Spatial gait asymmetry index

  The spatial gait asymmetry index was measured about the step length of the paretic and non-paretic leg through the portable GAITRite system. Lower scores indicate a more symmetrical pattern.

  2 months

• Temporal gait asymmetry index

  was measured about the single-limb support time of the paretic and non-paretic leg The temporal gait asymmetry index through the portable GAITRite system. Lower scores indicate a more symmetrical pattern.

  2 months

• Dynamic limit of postural stability

  The capacity to control and move the center of gravity in various directions across their base of support was assessed utilizing the Biodex balance system. Values are expressed as accuracy % and higher scores mean better balance capability.

  2 months

Secondary Outcomes (3)

• Six-minute walk test

  2 months

• Timed Up and Down Stair test

  2 months

• 10-meter Shuttle Run Test

  2 months

Study Arms (2)

Split-belt treadmill walking group

EXPERIMENTAL

Participants in this group performed repeated split-belt treadmill training with an error-augmentation strategy.

Other: Split-belt treadmill training

Control group

ACTIVE COMPARATOR

Participants in this group received the standard physical rehabilitation program

Other: Standard physical therapy

Interventions

Split-belt treadmill training OTHER

Participants in the split-belt walking group (experimental group) performed repeated split-belt treadmill training with an error-augmentation strategy (exaggeration of the initial step-length asymmetry) for 60 minutes, three times per week for 12 successive weeks. The training was conducted under close supervision of a licensed pediatric physical therapist according to safety performance guidelines defined by the American Academy of Pediatrics.

Split-belt treadmill walking group

Standard physical therapy OTHER

Participants in the control group received the standard physical therapy program. Each session lasted for 60 minutes, repeated three times a week, over 12 consecutive weeks. The program consisted of advanced balance training, gait training, postural and flexibility exercises, and strength training exercises.

Control group

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Unilateral cerebral palsy
• Age 10-16 years
• Motor function level I or II according to the Gross Motor Function Classification System.
• Spasticity level 1 or 1+ according to the Modified Ashworth Scale

You may not qualify if:

• Structural deformities/contractures
• Musculoskeletal or neural surgery in the last year
• BOTOX injection in the last 6 months.
• Cardiopulmonary disorders that could be exacerbated by exercise.
• Perceptual and/or behavioral disorders.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ragab K Elnaggar, PhD

  Prince Sattam Bin Abdulaziz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This was a single-blind protocol. The researcher who collected the data was blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A prospective, randomized controlled clinical trial

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: January 3, 2021
• Primary Completion: April 7, 2022
• Study Completion: April 7, 2022
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)