Viewing Study NCT05302102


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Study NCT ID: NCT05302102
Status: COMPLETED
Last Update Posted: 2022-04-05
First Post: 2022-03-21
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Unilateral Versus Bilateral Lower-Limb Plyometric Training in Children With Cerebral Palsy
Sponsor: Cairo University
Organization:

Study Overview

Official Title: Paretic-limb-only Plyometric Training Versus Volume-matched Double-limb Training for Ameliorating Balance Capability and Gait Symmetry in Adolescents With Unilateral Cerebral Palsy: A Comparative Study
Status: COMPLETED
Status Verified Date: 2022-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study was set out to compare the effect of paretic-limb-only plyometric training versus double-limb training on balance capability and gait symmetry in adolescents with unilateral cerebral palsy (U-CP). Sixty-nine children with U-CP were randomly allocated to the paretic-limb-only plyometric training group (n = 23; performed plyometric movements/exercises unilaterally using the paretic leg only), the double-limb plyometric training group (n = 23; performed plyometric movements/exercises bilaterally through both lower legs), or the Control group (n =23, received standard rehabilitation plus SSC exercises). All groups were assessed for gait-symmetry and balance capability pre and post-treatment.
Detailed Description: Sixty-nine children with U-CP were recruited from the Physical Therapy Outpatient Clinic of 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 12 and 18 years, were functioning at levels I or II according to the Gross Motor Function Classification System, and had spasticity level 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 preventing them from performing high-intense exercise training.

Outcome measures

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

All groups were trained for 45 minutes, twice per week, for 12 successive weeks. The paretic-limb-only plyometric training group performed plyometric movements/exercises unilaterally using the paretic leg only. The double-limb plyometric training group performed plyometric movements/exercises bilaterally through both lower legs. The plyometric training program consisted of five unilateral and five bilateral lower limb plyometrics in the form of hopping/bounding/jumping activities. The plyometric training was preceded by a warm-up for 5 minutes and ended up with a 5-min cooldown. 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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: