Clinical trial NCT06980246: Utility of Upper-Extremity Plyometrics in Children With Unilateral Cerebral Palsy
Official title: Clinical Utility of Upper-extremity Plyometrics for Enhancing Muscle Strength and Functional Capabilities in Children With Hemiparetic Cerebral Palsy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Prince Sattam Bin Abdulaziz University
First posted: 2025-05-20
Enrollment: 58
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, two-arm, randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This study was set out to evaluate the effect of a 12-week upper extremity plyometric exercise (Plyo-Ex) on muscle strength and upper extremity function in children with hemiparetic cerebral palsy (Hemi-CP). Fifty-eight children with Hemi-CP were randomly allocated to the Plyo-Ex group (n = 29, received Plyo-Ex program, twice/week, over 12 weeks) or the control group (n = 29, received standard exercise program). Both groups were assessed for muscle strength and upper extremity function before and after treatment.

Detailed description: Fifty-eight children with Hemi-CP were recruited from the Physical Therapy Outpatient Clinic of Prince Sattam Bin Abdulaziz University and three referral hospitals in Riyadh provenience, Saudi Arabia. Their age ranged between 10 and 15 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, demonstrated any cognitive issues, and if they had cardiopulmonary problems that could be exacerbated by exercise.

Outcome measures

Muscle strength: The peak isometric muscle strength of the shoulder flexors, abductors, external rotators, elbow extensors, and wrist extensors was measured using a hand-held dynamometer.

Unilateral upper-extremity function : The unimanual functional performance was assessed using Melbourne Assessment (MA).

Bimanual hand function:The biimanual functional performance was evaluated utilizing the Assisting Hand Assessment (AHA)

The Plyo-Ex group received a 12-week therapist-led Plyo-Ex training, for approximately 45 minutes per session, two times a week for 12 consecutive weeks, in conformity with the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The Plyo-Ex program consisted of ten unilateral and bilateral upper extremity exercises in the form of push-ups and ball slams/throws/passes activities. The Plyo-Ex program preceded with a warm-up for 5 minutes and ended with a cool-down for 5 minutes. The control group received the standard exercise program, 45 minutes per session, two times a week for 12 consecutive weeks. The program consisted of flexibility exercises, strength training, weight-bearing exercises, proprioceptive neuromuscular facilitation, coordination exercise, task-oriented training, and functional exercises.

Eligibility criteria: Inclusion Criteria:

* Unilateral cerebral palsy
* Age 10-15 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: Muscle strength
timeFrame: 2 months
Secondary outcomes:
measure: Unilateral upper-extremity function
timeFrame: 2 months
measure: Spontaneity of the upper extremity use
timeFrame: 2 months
measure: Dynamic positional alignment of the upper extremity
timeFrame: 2 months
measure: Grasp-release Ability
timeFrame: 2 months
measure: Bimanual hand function
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: