Cerebral Palsy Spastic HemiplegicUEU/CPNCT07233031
Effectiveness of Universal Exercise Unit Exercise on Upper Limb Strength Using Biodex Isokinetic
A study testing Experimental in people with Cerebral Palsy Spastic Hemiplegic, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to determine the role of designed program in the universal exercise unit on upper limb function and strength in children with spastic hemiplegia. forty children with spastic hemiplegia cerebral palsy from both sexes had been selected from the Outpatient Clinic of the Faculty of Physical… Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Cerebral Palsy Spastic Hemiplegic
- What is being tested?
- Experimental
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2024to 1 Sep 2025
- 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 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Their ages were ranged from 5-9 years old.
- They had spasticity grades 1, 1+ degree according to Modified Ashworth scale
- They were selected to be in level I and II GMFCs They were selected to be in level II MACs
Who cannot join
- Visual or hearing impairment
- Orthopedic surgery of upper limbs for the last 6 months
- Cardiopulmonary diseases
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of the Faculty of Physical Therapy, Cairo University's
Cairo, 11432
About this study
Official title: ROLE OF DESIGNED PROGRAM IN UNIVERSAL EXERCISE UNIT ON UPPER LIMB IN CHILDREN WITH SPASTIC HEMIPLEGIA
The aim of the study is to determine the role of designed program in the universal exercise unit on upper limb function and strength in children with spastic hemiplegia. forty children with spastic hemiplegia cerebral palsy from both sexes had been selected from the Outpatient Clinic of the Faculty of Physical Therapy, Cairo University . Children were divided into two groups of equal numbers; 20 patients in each group. Group A: Children in this group received a selected physical therapy program. Group B: Children in this group received a designed physical therapy program in UEU in addition to the selected physical therapy program. A-Materials for evaluation 1- For the Quality Of Upper Extremity Skill Test (QUEST),2- Biodex Isokinetic systems.Evaluation was carried out for each child individually before and after 3 months of treatment
Read the detailed description
This study is designed to answer the following question:
Is there an effect of designed program in universal exercise unit on upper limb function and strength in children with spastic hemiplegia? Purpose of The Study The purpose of the study is to determine the role of designed program in the universal exercise unit on upper limb function and strength in children with spastic hemiplegia.
Null Hypothesis Is there is no role of designed program in the universal exercise unit on the upper limb in children with spastic hemiplegia.
The study was concluded forty children with spastic hemiplegic cerebral palsy from both sexes had been selected from according to the following criteria:
- children ages were ranged from 5-9 years old.
- The children had spasticity grades 1, 1+ degree according to Modified Ashworth scale
- The children were selected to be in level I and II GMFCs
- The children were selected to be in level II MACs participants had been excluded if they had the following:
- Visual or hearing impairment
- Orthopedic surgery of upper limbs for the last 6 months
- Cardiopulmonary diseases Children were equally assigned into two groups using simple randomization, control group (A) and study group (B). Each group would consist of 20 children with spastic hemiplegia CP.
Group (A): Children in this group received a selected physical therapy program. Group (B): Children in this group received the selected physical therapy program in addition to a designed physical therapy program in UEU.
Evaluation was carried out for each child individually before and after 3 months of treatment.
A-For Assessment
- The Quality of Upper Extremity Skill Test (Quest) The QUEST test included 34 items in four domains of (dissociated movement, grasp, weight bearing and protective extension). Each child was instructed to hold the position for at least two seconds. The total testing timing including the administration and scoring was approximately 45 minutes. The scoring was performed and recorded in scoring box. Even if the item was not tested (I.e: yes, no, not tested)
- The Biodex Isokinetic system The testing session had been started with a warm up procedure, consisting of shoulder movements in all directions, push up-exercises against the wall and stretching. For the testing procedure, the closed chain attachment was fixed to the isokinetic dynamometer in a horizontal position. Essentially, this device converts rotational motion at the dynamometer into linear motion, allowing closed kinematic chain or linear movements The evaluation was carried out for each child individually before and after three month of treatment.
Tested muscles were elbow flexors, elbow extensor, shoulder flexors, shoulder extensors.
- Conditions
- Cerebral Palsy Spastic Hemiplegic
- Being tested
- Experimental, Control (Standard treatment)
- Keywords
- universal exercise unit , muscle strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalProcedure or surgery
designed physical therapy program in Universal exercise unit for strengthening upper limb. fundamental beginning position for every exercise. Total session time in the UEU was approximately 30 minutes.
The resisted exercise targeted shoulder flexor and extensor muscles, shoulder abductor and adductor muscles and for elbow extensor muscles
Control (Standard treatment)Other
traditional physio therapy program.
| Study group | Role | What they receive |
|---|---|---|
| control (standard treatment) | Active comparator | children in control group received standard physiotherapy Receives: Other: Control (Standard treatment) |
| experimental | Experimental | a designed physical therapy program in Universal exercise that began with testing one repetition maximum (1-RM). One repetition maximum (1-RM) was determined through the chest press. children had been targeted upper limb strengthening program Receives: Procedure: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Quality of Upper Extremity Skill Test
The Quality of Upper Extremity Skill est test included 34 items in four domains of dissociated movement, grasp, weight bearing and protective extension. All children in this study were assessed in the four domains. The total number of 'yes' and 'no' responses provide the raw score for each domain. This is then weighted and transformed into a final score range of zero to 100.
Measured: The total testing timing including the administration and scoring was approximately 45 minutes. The scoring was performed and recorded in scoring box. Even if the item was not tested (I.e: yes, no, not tested)
Secondary outcomes (1)
The Biodex Isokinetic system
The testing session had been started with a warm up procedure, consisting of shoulder movements in all directions, push up-exercises against the wall and stretching Tested muscles were elbow flexors, elbow extensor, shoulder abductors, shoulder adductors
Measured: The evaluation was carried out for each child individually before and after three month of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start10 Apr 2024
- Primary completion20 Apr 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy Spastic HemiplegicStudies 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
- for group A: The session time ranged between 50-60 minutes according to child cooperation and numbers of repetitions the child could do for group B: Each child performed 1 or 2 sets of 8-15 repetitions with a light to moderate load (about 60% 1- RM)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samaa Hussein Rajab, Cairo University
- Investigators
- Naglaa A Zaky, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233031
- Sponsor's protocol ID
- P.T.REC/012/004849
- Acronym
- UEU/CP
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROLE OF DESIGNED PROGRAM IN UNIVERSAL EXERCISE UNIT ON UPPER LIMB IN CHILDREN WITH SPASTIC HEMIPLEGIA
- ClinicalTrials.gov ID
- NCT07233031
- Acronym / sponsor ID
- UEU/CP / P.T.REC/012/004849
- Conditions
- Cerebral Palsy Spastic Hemiplegic
- Keywords
- universal exercise unit , muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 18 Nov 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.
The aim of the study is to determine the role of designed program in the universal exercise unit on upper limb function and strength in children with spastic hemiplegia. forty children with spastic hemiplegia cerebral palsy from both sexes had been selected from the Outpatient Clinic of the Faculty of Physical Therapy, Cairo University . Children were divided into two groups of equal numbers; 20 patients in each group. Group A: Children in this group received a selected physical therapy program. Group B: Children in this group received a designed physical therapy program in UEU in addition to the selected physical therapy program. A-Materials for evaluation 1- For the Quality Of Upper Extremity Skill Test (QUEST),2- Biodex Isokinetic systems.Evaluation was carried out for each child individually before and after 3 months of treatment
Detailed description
This study is designed to answer the following question:
Is there an effect of designed program in universal exercise unit on upper limb function and strength in children with spastic hemiplegia? Purpose of The Study The purpose of the study is to determine the role of designed program in the universal exercise unit on upper limb function and strength in children with spastic hemiplegia.
Null Hypothesis Is there is no role of designed program in the universal exercise unit on the upper limb in children with spastic hemiplegia.
The study was concluded forty children with spastic hemiplegic cerebral palsy from both sexes had been selected from according to the following criteria:
- children ages were ranged from 5-9 years old.
- The children had spasticity grades 1, 1+ degree according to Modified Ashworth scale
- The children were selected to be in level I and II GMFCs
- The children were selected to be in level II MACs participants had been excluded if they had the following:
- Visual or hearing impairment
- Orthopedic surgery of upper limbs for the last 6 months
- Cardiopulmonary diseases Children were equally assigned into two groups using simple randomization, control group (A) and study group (B). Each group would consist of 20 children with spastic hemiplegia CP.
Group (A): Children in this group received a selected physical therapy program. Group (B): Children in this group received the selected physical therapy program in addition to a designed physical therapy program in UEU.
Evaluation was carried out for each child individually before and after 3 months of treatment.
A-For Assessment
- The Quality of Upper Extremity Skill Test (Quest) The QUEST test included 34 items in four domains of (dissociated movement, grasp, weight bearing and protective extension). Each child was instructed to hold the position for at least two seconds. The total testing timing including the administration and scoring was approximately 45 minutes. The scoring was performed and recorded in scoring box. Even if the item was not tested (I.e: yes, no, not tested)
- The Biodex Isokinetic system The testing session had been started with a warm up procedure, consisting of shoulder movements in all directions, push up-exercises against the wall and stretching. For the testing procedure, the closed chain attachment was fixed to the isokinetic dynamometer in a horizontal position. Essentially, this device converts rotational motion at the dynamometer into linear motion, allowing closed kinematic chain or linear movements The evaluation was carried out for each child individually before and after three month of treatment.
Tested muscles were elbow flexors, elbow extensor, shoulder flexors, shoulder extensors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- for group A: The session time ranged between 50-60 minutes according to child cooperation and numbers of repetitions the child could do for group B: Each child performed 1 or 2 sets of 8-15 repetitions with a light to moderate load (about 60% 1- RM)
| Arm | Type | Receives |
|---|---|---|
| control (standard treatment) | Active comparator | Other: Control (Standard treatment)children in control group received standard physiotherapy |
| experimental | Experimental | Procedure: Experimentala designed physical therapy program in Universal exercise that began with testing one repetition maximum (1-RM). One repetition maximum (1-RM) was determined through the chest press. children had been targeted upper limb strengthening program |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Their ages were ranged from 5-9 years old.
- They had spasticity grades 1, 1+ degree according to Modified Ashworth scale
- They were selected to be in level I and II GMFCs They were selected to be in level II MACs
Key exclusion criteria (3 listed)
- Visual or hearing impairment
- Orthopedic surgery of upper limbs for the last 6 months
- Cardiopulmonary diseases
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 |
|---|---|---|
| Experimentaldesigned physical therapy program in Universal exercise unit for strengthening upper limb. fundamental beginning position for every exercise. Total session time in the UEU was approximately 30 minutes. The resisted exercise targeted shoulder flexor and extensor muscles, shoulder abductor and adductor muscles and for elbow extensor muscles | Procedure or surgery | experimental |
| Control (Standard treatment)traditional physio therapy program. | Other | control (standard treatment) |
Primary outcome
The Quality of Upper Extremity Skill Test
Time frame: The total testing timing including the administration and scoring was approximately 45 minutes. The scoring was performed and recorded in scoring box. Even if the item was not tested (I.e: yes, no, not tested)
The Quality of Upper Extremity Skill est test included 34 items in four domains of dissociated movement, grasp, weight bearing and protective extension. All children in this study were assessed in the four domains. The total number of 'yes' and 'no' responses provide the raw score for each domain. This is then weighted and transformed into a final score range of zero to 100.
1 secondary outcome
The Biodex Isokinetic system
Time frame: The evaluation was carried out for each child individually before and after three month of treatment.
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 18 Nov 2025.
- 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.
Naglaa A Zaky, professor study director
Cairo 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 Experimental in people with Cerebral Palsy Spastic Hemiplegic, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 3 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 18 Nov 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 Egypt. 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?
The Quality of Upper Extremity Skill Test (time frame: The total testing timing including the administration and scoring was approximately 45 minutes. The scoring was performed and recorded in scoring box. Even if the item was not tested (I.e: yes, no, not tested)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2025.