Hemiplegic Cerebral PalsyNCT05718388
Contralateral Isokinetic Training on Strength and Reaching Skill
A study testing Physical therapy exercises and Isokinetic training in people with Hemiplegic Cerebral Palsy, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
The study aimed to ascertain how cross-education affected the activity of the paretic muscles in the upper limb and how that affected function in children with spastic hemiplegia and cerebral palsy. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- Physical therapy exercises and Isokinetic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 20 Jan 2023
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- hemiplegic CP children from both genders with age ranged from five to seven year
- had mild to moderate spasticity according to the Modified Ashworth Scale
- able to follow verbal instructions
- able to stand unassisted and ambulate with abnormal pattern
Who cannot join
- children who had any visual or auditory problems, fixed deformities in upper limb that interfere with fine motor functions, with history of any surgical interference in upper limbs for less than one year, and un-cooperative children were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Contralateral Isokinetic Training on Strength and Reaching Skill in Children With Spastic Hemiplegic Cerebral Palsy
The study aimed to ascertain how cross-education affected the activity of the paretic muscles in the upper limb and how that affected function in children with spastic hemiplegia and cerebral palsy. Additionally, it sought to determine how unilateral isokinetic resistance training affected children with spastic hemiplegia of the contralateral limb in terms of strength development.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- Physical therapy exercises, Isokinetic training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy exercisesOther
For two consecutive months, the children in control group underwent a physiotherapy program for 60min/ three sessions each week: it was based mainly on the neurodevelopment technique, directed toward inhibiting abnormal muscle tone facilitating normal patterns of postural control and hand functions training program
Isokinetic trainingOther
Children in study group received the same program given to control group (A) in addition to isokinetic resistance training of the less affected upper limb for shoulder abductors in concentric mode at the angular velocity of 180 degree/ second under full supervision on the Biodex isokinetic dynamometer three times per week for 8 weeks, making a total of 24 training sessions. Each child was trained in the seated position with the similar precaution of the testing protocol.
| Study group | Role | What they receive |
|---|---|---|
| Control group (A) | Other | They received a physiotherapy program Receives: Other: Physical therapy exercises |
| study Group (B) | Experimental | They received the same program given to control group (A) in addition to isokinetic resistance training of the less affected upper limb for shoulder abductors in concentric mode at the angular velocity of 180 degree/ second Receives: Other: Isokinetic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentric isokinetic shoulder abductors peak torque in Newton- meters and average power.
Isokinetic dynamometer was used to measure the concentric isokinetic shoulder abductors peak torque in Newton- meters and average power at an angular velocity of 180 degrees per second in concentric mode with gravity adjustment
Measured: Change from Baseline Isokinetic dynamometer parameters at 2 months
Secondary outcomes (1)
Modified functional scale for reaching
It was used to measure the ability of the child to perform the reaching skills. It was used to determine the level of performance and functional improvement in reaching skills. Each child was seated in front of a table, in a chair adjustable to his or her height. They were appropriately fitted and supported to avoid any substitution movement from the child's trunk. The target was positioned on the top of the table, beside the child. The child's elbow was passively placed at full extension and the writ in natural position. Each trail of the reaching task was begun with the child's arm straight and parallel to the patient's trunk. The child was asked to make accurate reaching to touch the target by the affected arm when the examiner gives the command.
Measured: Change from Baseline Modified functional scale for reaching at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 May 2022
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Hussin Hussin Mohammed, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718388
- Sponsor's protocol ID
- contralateral isokinetic
- Status last verified
- Feb 2023
- First submitted
- 21 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Contralateral Isokinetic Training on Strength and Reaching Skill in Children With Spastic Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05718388
- Acronym / sponsor ID
- contralateral isokinetic
- Conditions
- Hemiplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 8 Feb 2023 (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 study aimed to ascertain how cross-education affected the activity of the paretic muscles in the upper limb and how that affected function in children with spastic hemiplegia and cerebral palsy. Additionally, it sought to determine how unilateral isokinetic resistance training affected children with spastic hemiplegia of the contralateral limb in terms of strength development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (A) | Other | Other: Physical therapy exercisesThey received a physiotherapy program |
| study Group (B) | Experimental | Other: Isokinetic trainingThey received the same program given to control group (A) in addition to isokinetic resistance training of the less affected upper limb for shoulder abductors in concentric mode at the angular velocity of 180 degree/ second |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- hemiplegic CP children from both genders with age ranged from five to seven year
- had mild to moderate spasticity according to the Modified Ashworth Scale
- able to follow verbal instructions
- able to stand unassisted and ambulate with abnormal pattern
Key exclusion criteria (1 listed)
- children who had any visual or auditory problems, fixed deformities in upper limb that interfere with fine motor functions, with history of any surgical interference in upper limbs for less than one year, and un-cooperative children were excluded.
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 |
|---|---|---|
| Physical therapy exercisesFor two consecutive months, the children in control group underwent a physiotherapy program for 60min/ three sessions each week: it was based mainly on the neurodevelopment technique, directed toward inhibiting abnormal muscle tone facilitating normal patterns of postural control and hand functions training program | Other | Control group (A) |
| Isokinetic trainingChildren in study group received the same program given to control group (A) in addition to isokinetic resistance training of the less affected upper limb for shoulder abductors in concentric mode at the angular velocity of 180 degree/ second under full supervision on the Biodex isokinetic dynamometer three times per week for 8 weeks, making a total of 24 training sessions. Each child was trained in the seated position with the similar precaution of the testing protocol. | Other | study Group (B) |
Primary outcome
Concentric isokinetic shoulder abductors peak torque in Newton- meters and average power.
Time frame: Change from Baseline Isokinetic dynamometer parameters at 2 months
Isokinetic dynamometer was used to measure the concentric isokinetic shoulder abductors peak torque in Newton- meters and average power at an angular velocity of 180 degrees per second in concentric mode with gravity adjustment
1 secondary outcome
Modified functional scale for reaching
Time frame: Change from Baseline Modified functional scale for reaching at 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 8 Feb 2023.
- Individual participant dataSharing planned: No
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Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy exercises and Isokinetic training in people with Hemiplegic Cerebral Palsy, run by Delta University for Science and Technology 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 4 inclusion and 1 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 8 Feb 2023. 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?
Concentric isokinetic shoulder abductors peak torque in Newton- meters and average power. (time frame: Change from Baseline Isokinetic dynamometer parameters at 2 months). 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 8 Feb 2023; AzTrials last refreshed its copy on 29 Oct 2026.