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

NCT ID: NCT05350241

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-03
• Study Completion Date: 2022-04-07

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.

Detailed Description

Fifty-two children with ULCP were recruited from the Physical Therapy Outpatient Clinic of the College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, King Khalid Hospital, and a tertiary referral hospital, Al-Kharj, Saudi Arabia. Their age ranged between 10 and 16 years, were functioning at levels I or II according to the Gross Motor Function Classification System, and had spasticity levels 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had fixed deformities, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, had attentional neglect, and if they had cardiopulmonary problems that could be exacerbated by exercise.

Outcome measures

1. Gait-symmetry Indices: Gait symmetry indices (Spatial and temporal) were measured through the portable GAITRite system.

2. Dynamic balance: The directional dynamic limit of stability (forward, backward, paretic, and non-paretic) and overall limit of stability were assessed using the Biodex balance system.

3. Locomotor capacity: This was assessed through the 6-minute walk test (6-MWT), the Timed Up and Down Stair test (TUDS), and the 10-meter Shuttle Run Test (10mSRT).

Both groups were trained for one hour, three times a week, for 12 successive weeks. The split-belt treadmill walking group performed repetitive split-belt treadmill training with an error-augmentation strategy (i.e., exaggeration of the initial step-length asymmetry). The control group received the standard rehabilitation program, which comprised advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Split-belt treadmill walking group

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

Group Type: EXPERIMENTAL

Split-belt treadmill training

Intervention Type: 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.

Control group

Participants in this group received the standard physical rehabilitation program

Group Type: ACTIVE_COMPARATOR

Standard physical therapy

Intervention Type: 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.

Interventions

Split-belt treadmill training

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.

Intervention Type: OTHER

Standard physical therapy

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ragab Kamal Elnaggar

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ragab K Elnaggar, PhD

Role: PRINCIPAL_INVESTIGATOR

Prince Sattam Bin Abdulaziz University

Locations

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

RHPT/0021/0017

Identifier Type: -

Identifier Source: org_study_id