Clinical trial NCT05350241: Repetitive Split-Belt Treadmill Perturbation in Children With Unilateral Cerebral Palsy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 52
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized controlled clinical trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Spatial gait asymmetry index
timeFrame: 2 months
measure: Temporal gait asymmetry index
timeFrame: 2 months
measure: Dynamic limit of postural stability
timeFrame: 2 months
Secondary outcomes:
measure: Six-minute walk test
timeFrame: 2 months
measure: Timed Up and Down Stair test
timeFrame: 2 months
measure: 10-meter Shuttle Run Test
timeFrame: 2 months
Other outcomes:
Locations:
city: Al Kharj
country: Saudi Arabia
facility: Ragab K. Elnaggar
state: Riyadh
Study officials:
affiliation: Prince Sattam Bin Abdulaziz University
name: Ragab K Elnaggar, PhD
role: PRINCIPAL_INVESTIGATOR
References: