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

Exploring Temporospatial Gait Asymmetry, Dynamic Balance, and Locomotor Capacity After a 12-month Split-belt Treadmill Training in Adolescents With Unilateral Cerebral Palsy: A Randomized Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Split-belt treadmill training; Other: Standard physical therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh
    • Al Kharj, Riyadh, Saudi Arabia
      • Ragab K. Elnaggar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Split-belt treadmill walking group; Participants in this group performed repeated split-belt treadmill training with an error-augmentation strategy.	Other: 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.
Active Comparator: Control group; Participants in this group received the standard physical rehabilitation program	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute walk test	The six-minute walk test measured the walking distance that children were able to cover across a 30-m walkway with a self-determined walking pace over six minutes. A longer distance indicates a better performance.	2 months
Timed Up and Down Stair test	The Timed Up and Down Stair test assessed the capacity (as time in seconds) to walk up and down a stair flight (14 steps, each was 20-cm in height). A shorter time to complete indicates better performance.	2 months
10-meter Shuttle Run Test	The 10-meter Shuttle Run Test measured the children's ability to walk and run at a faster rate. The test was performed twice over a 10-m path, and the better (faster) trial was recorded.	2 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2021
• Primary Completion (Actual): April 7, 2022
• Study Completion (Actual): April 7, 2022

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: RHPT/0021/0017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No