Cerebral PalsyNCT06980246
Utility of Upper-Extremity Plyometrics in Children With Unilateral Cerebral Palsy
A study testing Plyometric Exercise and Standard exercise program in people with Cerebral Palsy, run by Cairo University at 1 site in Saudi Arabia.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Plyometric Exercise and Standard exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 12 Feb 2023to 4 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Plyometric Exercise, Standard exercise program
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plyometric ExerciseOther
The Plyo-Ex program was conducted for 45 minutes/session twice weekly over 12 weeks. The program was directed by a pediatric physical therapist in accordance with the safety performance guidelines defined by the American Academy of Pediatrics and the US National Strength and Conditioning Association. The program consisted of ten unilateral and bilateral upper extremity exercises in the form of push-ups and ball slams/throws/passes activities and was preceded by a warm-up for 5 minutes and ended with a cool-down for 5 minutes.
Standard exercise programOther
The standard exercise program lasted for 45 minutes/session and repeated two times a week for 12 consecutive weeks. The program was conducted by a pediatric physical therapist and consisted of flexibility exercises, strength training, weight-bearing exercises, proprioceptive neuromuscular facilitation, coordination exercise, and functional training.
| Study group | Role | What they receive |
|---|---|---|
| Plyo-Ex group | Experimental | Children in this group received the Plyo-Ex program Receives: Other: Plyometric Exercise |
| Control group | Active comparator | Children in this group received the standard exercise program. Receives: Other: Standard exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
The peak isometric muscle strength (Kg) was measured using a hand-held dynamometer
Measured: 2 months
Secondary outcomes (5)
Unilateral upper-extremity function
The unilateral upper-extremity function was assessed using the Melbourne Assessment (MA), which includes 16 standardized tasks assessing reaching, grasping, releasing, and manipulation. It was administered with the child seated at a table, and sessions were video recorded for later scoring. Each task is scored on a 3-5-point scale based on movement quality, accuracy, fluency, dexterity, and speed, yielding 37 sub-scores. Total scores (max 122) are converted to a percentage; higher values indicate better function.
Measured: 2 months
Spontaneity of the upper extremity use
Spontaneity of upper extremity use was assessed using the Shriners Hospital Upper Extremity Evaluation (SHUEE), a video-based tool that evaluates spontaneous movement of the elbow, forearm, wrist, thumb, and fingers during 9 out of 16 standardized tasks. The Spontaneous Functional Analysis (SFA) score is rated on a 6-point scale (0 = no use, 5 = optimal use), with a maximum score of 45 indicating normal spontaneous function.
Measured: 2 months
Dynamic positional alignment of the upper extremity
The dynamic positional alignment (DPA) of the upper extremity was evaluated using the Shriners Hospital Upper Extremity Evaluation (SHUEE), a video-based assessment that examines the alignment of five segments (thumb, fingers, wrist, forearm, elbow) during 16 standardized tasks. For DPA, each segment is scored across four tasks using a 4-point scale (0 = poor alignment, 3 = normal alignment). Total DPA score is the sum of all segment scores, with a maximum of 72 indicating optimal alignment.
Measured: 2 months
Grasp-release Ability
The grasp-release ability (GRA) was assessed using the Shriners Hospital Upper Extremity Evaluation (SHUEE), a video-based tool that evaluates the ability to grasp and release objects with the wrist in flexion, neutral, and extended positions. Each trial is scored on a binary scale (0 = cannot perform, 1 = can perform), with a maximum score of 6 indicating normal or optimal function
Measured: 2 months
Bimanual hand function
The bimanual hand function was assessed using the Assisting Hand Assessment (AHA), a standardized tool for children and adolescents (18 months to 18 years) with unilateral disabilities. It evaluates use of the affected hand during 22 bimanual tasks, scored on a 4-point scale. Raw scores range from 22 to 88, with higher scores indicating better performance. Results were converted to logit-based AHA units (0-100) and reported as such.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start12 Feb 2023
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, two-arm, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University
- Responsible party
- Principal investigator, Ragab Kamal Elnaggar, Cairo University
- Investigators
- Ragab K Elnaggar, PhD, Principal investigator, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980246
- Sponsor's protocol ID
- RHPT/0023/0013
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elnaggar RK, Ramirez-Campillo R, Elfakharany MS, Alrawaili SM, Alghadier M, Alotaibi MA, El-Basatiny HM, Elsaeed TM. Task-Oriented Plyometric Intervention for Augmenting Upper Extremity Strength and Function in Hemiparetic Cerebral Palsy: A Randomized Controlled Trial. NeuroRehabilitation. 2026 Feb;58(1):50-61. doi: 10.1177/10538135251400762. Epub 2025 Dec 24.
PubMed 41442215
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06980246
- Acronym / sponsor ID
- RHPT/0023/0013
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University
- Study start
- 12 Feb 2023 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, two-arm, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Plyo-Ex group | Experimental | Other: Plyometric ExerciseChildren in this group received the Plyo-Ex program |
| Control group | Active comparator | Other: Standard exercise programChildren in this group received the standard exercise program. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plyometric ExerciseThe Plyo-Ex program was conducted for 45 minutes/session twice weekly over 12 weeks. The program was directed by a pediatric physical therapist in accordance with the safety performance guidelines defined by the American Academy of Pediatrics and the US National Strength and Conditioning Association. The program consisted of ten unilateral and bilateral upper extremity exercises in the form of push-ups and ball slams/throws/passes activities and was preceded by a warm-up for 5 minutes and ended with a cool-down for 5 minutes. | Other | Plyo-Ex group |
| Standard exercise programThe standard exercise program lasted for 45 minutes/session and repeated two times a week for 12 consecutive weeks. The program was conducted by a pediatric physical therapist and consisted of flexibility exercises, strength training, weight-bearing exercises, proprioceptive neuromuscular facilitation, coordination exercise, and functional training. | Other | Control group |
Primary outcome
Muscle strength
Time frame: 2 months
The peak isometric muscle strength (Kg) was measured using a hand-held dynamometer
5 secondary outcomes
Unilateral upper-extremity function
Time frame: 2 months
Spontaneity of the upper extremity use
Time frame: 2 months
Dynamic positional alignment of the upper extremity
Time frame: 2 months
Grasp-release Ability
Time frame: 2 months
Bimanual hand function
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Derived from this study: PubMed 41442215Elnaggar RK, Ramirez-Campillo R, Elfakharany MS, Alrawaili SM, Alghadier M, Alotaibi MA, El-Basatiny HM, Elsaeed TM. Task-Oriented Plyometric Intervention for Augmenting Upper Extremity Strength and Function in Hemiparetic Cerebral Palsy: A Randomized Controlled Trial. NeuroRehabilitation. 2026 Feb;58(1):50-61. doi: 10.1177/10538135251400762. Epub 2025 Dec 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragab K Elnaggar, PhD principal investigator
Prince Sattam Bin Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plyometric Exercise and Standard exercise program in people with Cerebral Palsy, run by Cairo University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06980246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.