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NCT Number: NCT05302102

Unilateral Versus Bilateral Lower-Limb Plyometric Training in Children With Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral cerebral palsy
  • Age 12-18 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 interfere with the ability to engage in exercise training.
  • Perceptual and/or behavioral disorders.

Treatment and study plan

Unilateral plyometric training

Other

The paretic-limb-only plyometric training group received a plyometric exercise program performed unilaterally through the paretic leg only for 45 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 and the US National Strength and Conditioning Association.

Bilateral plyometric training

Other

The double-limb plyometric training group received a plyometric exercise program performed bilaterally through the paretic and non-paretic legs for 45 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 and the US National Strength and Conditioning Association.

Standard physical therapy

Other

The control group received the standard physical rehabilitation program conducted for 45 minutes, thrice a week for 12 consecutive weeks, and consisted of advanced balance training, gait training, postural and flexibility exercises, and strength training exercises.

Primary outcomes

  1. Spatial gait symmetry

    Time frame: 2 months

    The spatial gait symmetry 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. Temporal gait symmetry

    Time frame: 2 months

    The temporal gait symmetry index was measured about the single-limb support time of the paretic and non-paretic leg through the portable GAITRite system. Lower scores indicate a more symmetrical pattern

  3. Limit of postural stability

    Time frame: 2 months

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 31, 2022
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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