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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05350241
Enrollment
52
Registered
2022-04-28
Start date
2021-01-03
Completion date
2022-04-07
Last updated
2022-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

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.

Interventions

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.

OTHERStandard 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

This was a single-blind protocol. The researcher who collected the data was blinded to the treatment allocation.

Intervention model description

A prospective, randomized controlled clinical trial

Eligibility

Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Spatial gait asymmetry index2 monthsThe 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.
Temporal gait asymmetry index2 monthswas 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.
Dynamic limit of postural stability2 monthsThe 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.

Secondary

MeasureTime frameDescription
Six-minute walk test2 monthsThe 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.
Timed Up and Down Stair test2 monthsThe 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.
10-meter Shuttle Run Test2 monthsThe 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.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026