Cerebral Palsy (CP)CHRISTNCT06748235
Comprehensive Hand Repetation Intensive Strength Training on Upper Limb in Children With Cerebral Palsy
A study testing Intensive Strength Training and Routine Physical Therapy in people with Cerebral Palsy (CP), run by Riphah International University at 2 sites in Pakistan.
Trial summary
Hemiplegia is the medical term for paralysis of one side of the body This means their shoulder; arm, hand, leg and foot are all completely paralyzed.. It results in muscular wasting on the affected side, impairs gait, reduces motor abilities, and causes instability and a loss of grasping capacity. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Intensive Strength Training and Routine Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesPakistan
- Study dates
- 25 Sep 2024to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 6 to 12 years will be included
- Both genders will be included
- GMFCS I and II
- Children who have normal communication skills and cognitive functions will be included
Who cannot join
- Children having damage to the musculoskeletal system including fracture of the upper limb and contracture will be excluded
- Children who have undergone the administration of medicine influencing muscular strength and spasticity will be excluded
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
Riphah International University
Lahore, Punjab Province, 54000
Imran Amjad, PhD, 9233224390125, Imran.amjad@riphah.edu.pk
Muhammad Asif Javed, MS, 03224209422, a.javed@riphah.edu.pk
- Recruiting
Riphah International University
Lahore, Punjab Province
Imran Amjad, PhD, 9233224390125, Imran.amjad@riphah.edu.pk
Muhammad Asif Javed, MS, 03224209422, a.javed@riphah.edu.pk
About this study
Official title: Effects of Comprehensive Hand Repetition Intensive Strength Training on Upper LIMB Function in Children With Cerebral Palsy
Hemiplegia is the medical term for paralysis of one side of the body This means their shoulder; arm, hand, leg and foot are all completely paralyzed.. It results in muscular wasting on the affected side, impairs gait, reduces motor abilities, and causes instability and a loss of grasping capacity. The patient\'s quality of life is impacted by hemiplegia because it impairs brain and spinal cord functions Hemiplegic cerebral palsy is the type of cerebral palsy in which there is absolutely no use of one side of the body. This means their shoulder; arm, hand, leg and foot are all completely paralyzed. Hemiplegia in infants and children is a type of Cerebral Palsy that results from damage to the part (hemisphere) of the brain that controls muscle movements. This damage may occur before, during or shortly after birth. The term hemiplegia means that the paralysis is on one vertical half of the body.
Read the detailed description
The Comprehensive Hand Repetitive Intensive Strength Training (CHRIST) program is designed to provides special training for enhancing muscular strength of the upper limb.
The current study will be a randomized control trial, and data will be collected from Ittefaq Hospital Lahore Pakistan. The study will include 30 patients equally divided into two groups experimental group included 15 patients, and the control group included 15 patients and was randomly allocated. The inclusion criteria for the study will be Comprehensive Hand Repetitive Intensive Strength Training on the upper limb of CP patients with age between 6 to 12 years and both genders will be included children who have normal communication skills and cognitive function will be included and give 30 minutes per session three sessions in a week and total 30 sessions per ten weeks and to normalize muscle tone and patient able to perform ADLS.
Children having damaged musculoskeletal system including fracture of upper limb and contracture will be excluded children having undergone administration of medicine influencing muscular strength and spasticity will be excluded tools used for data collection are Jebsen-Taylor Hand Function Test and ABIL Hand for upper limb and data will be analyzed by SPSS version 26.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Intensive Strength Training, Routine Physical Therapy
- Keywords
- Cerebral palsy, Muscle strength, Upper extremity
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Strength TrainingOther
Comprehensive Hand Repetitive Intensive Strength Training and Routine Physical Therapy 60 minutes per session, three sessions a week, at a total of 30 sessions per ten weeks. Comprehensive hand repetitive intensive strength training included treadmill training for the upper limb with body weight supporting the using upper limb. The posture of an arm swing was to maintain the joints of the elbows and wrist as much as possible, and the shoulder joint was allowed to be flexed by 160 degrees .The posture of the arm stance supported the weight using metacarpal heads, hands, and elbows, and the shoulder joints were allowed to be flexed by 90 degrees.
Routine Physical TherapyOther
Received 60 minutes per a session, three sessions a week, at a total of 30 sessions per 10 weeks by creating a home program, which consisted of a total of 8 exercises that enhanced the muscular strength of the upper limb including the triceps brachii and extensor carpi radialis, and conveyed an effect of reaching the muscles out. flexion and extension muscle strengthening with towel, hand grip and wrist extension muscle strengthening This exercise consisted of shoulder extension muscle, elbow flexion muscle, shoulder abduction muscle, and elbow extension muscle strengthening with a thera band, as well as hand grip, forearm with a velcro board, wrist extension muscle strengthening with sandbag and shoulder abduction-extension muscle strengthening with a thera band.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group will received Comprehensive Hand Repetitive Intensive Strength Training | Experimental | Physical Therapy 60 minutes per session, three sessions a week, at a total of 30 sessions per ten weeks. Comprehensive hand repetitive intensive strength training included treadmill training for the upper limb with body weight supporting the using upper limb. The posture of an arm swing was to maintain the joints of the elbows and wrist as much as possible, and the shoulder joint was allowed to be flexed by 160 degrees. Receives: Other: Intensive Strength Training |
| Routine Physical Therapy | Other | control will received 60 minutes per a session, three sessions a week, at a total of 30 sessions per 10 weeks by creating a home program, which consisted of a total of 8 exercises that enhanced the muscular strength of the upper limb including the triceps brachii and extensor carpi radialis, and conveyed an effect of reaching the muscles out. Receives: Other: Routine Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jebsen-Taylor Hand Function Test (JTHFT)
The Jebsen-Taylor Hand Function Test (JTHFT) is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL). The JTHFT has seven subsets which are writing, simulated page-turning, lifting small objects, stimulated tree feeding, stacking, and lifting large, lightweight, and heavy objects. [JTHFT finds easy applicability in clinical settings since it can be administered in a short time by using readily available materials. Several studies report that the JTHFT is a valid assessment tool for the measurement of hand dysfunctions from a variety of patient populations having high reliability were (0.84-0.94 )
Measured: 15 to 30 minutes
ABIL HAND
ABILHAND-Kids Survey, which evaluates upper extremity function in children with cerebral palsy ABILHAND-Kids survey evaluates the bilateral upper extremities of children, and which has proven validity and reliability were 0.96 and 0.70 , including 21 questions for families related to the common tasks undertaken by their children in their daily living activities. The ABILHAND-Kids survey was originally developed in French as a standard means of assessment of manual ability in children with CP. This survey evaluates the most typical indicators of manual activity, in which some of the items were developed based on the ABILHAND-Kids survey, which was developed to assess manual ability in adult patients, while other items were selected from existing scales or were adapted to broaden the variability of activities
Measured: 10 - 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start25 Sep 2024
- Primary completion25 Dec 2024 (estimated)
- Study completion10 Jan 2025 (estimated)
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 Palsy (CP)Studies 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
- Model description
- It will be randomized control trial in which non probability convenient sampling will be used. Two groups of 6-12 age will be formed in which participants will be randomly divided. Group A will be receive Group-Task-Oriented Training. Group B will be receive routine therapy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nisha Feroz, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748235
- Sponsor's protocol ID
- REC/RCR/AHS/24/NISHA
- Acronym
- CHRIST
- Status last verified
- Dec 2024
- First submitted
- 3 Nov 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kara OK, Yardimci BN, Sahin S, Orhan C, Livanelioglu A, Soylu AR. Combined Effects of Mirror Therapy and Exercises on the Upper Extremities in Children with Unilateral Cerebral Palsy: A Randomized Controlled Trial. Dev Neurorehabil. 2020 May;23(4):253-264. doi: 10.1080/17518423.2019.1662853. Epub 2019 Sep 13.
PubMed 31514564
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Comprehensive Hand Repetition Intensive Strength Training on Upper LIMB Function in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06748235
- Acronym / sponsor ID
- CHRIST / REC/RCR/AHS/24/NISHA
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Cerebral palsy, Muscle strength, Upper extremity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 25 Dec 2024 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 27 Dec 2024 (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.
Hemiplegia is the medical term for paralysis of one side of the body This means their shoulder; arm, hand, leg and foot are all completely paralyzed.. It results in muscular wasting on the affected side, impairs gait, reduces motor abilities, and causes instability and a loss of grasping capacity. The patient\'s quality of life is impacted by hemiplegia because it impairs brain and spinal cord functions Hemiplegic cerebral palsy is the type of cerebral palsy in which there is absolutely no use of one side of the body. This means their shoulder; arm, hand, leg and foot are all completely paralyzed. Hemiplegia in infants and children is a type of Cerebral Palsy that results from damage to the part (hemisphere) of the brain that controls muscle movements. This damage may occur before, during or shortly after birth. The term hemiplegia means that the paralysis is on one vertical half of the body.
Detailed description
The Comprehensive Hand Repetitive Intensive Strength Training (CHRIST) program is designed to provides special training for enhancing muscular strength of the upper limb.
The current study will be a randomized control trial, and data will be collected from Ittefaq Hospital Lahore Pakistan. The study will include 30 patients equally divided into two groups experimental group included 15 patients, and the control group included 15 patients and was randomly allocated. The inclusion criteria for the study will be Comprehensive Hand Repetitive Intensive Strength Training on the upper limb of CP patients with age between 6 to 12 years and both genders will be included children who have normal communication skills and cognitive function will be included and give 30 minutes per session three sessions in a week and total 30 sessions per ten weeks and to normalize muscle tone and patient able to perform ADLS.
Children having damaged musculoskeletal system including fracture of upper limb and contracture will be excluded children having undergone administration of medicine influencing muscular strength and spasticity will be excluded tools used for data collection are Jebsen-Taylor Hand Function Test and ABIL Hand for upper limb and data will be analyzed by SPSS version 26.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It will be randomized control trial in which non probability convenient sampling will be used. Two groups of 6-12 age will be formed in which participants will be randomly divided. Group A will be receive Group-Task-Oriented Training. Group B will be receive routine therapy
| Arm | Type | Receives |
|---|---|---|
| Experimental group will received Comprehensive Hand Repetitive Intensive Strength Training | Experimental | Other: Intensive Strength TrainingPhysical Therapy 60 minutes per session, three sessions a week, at a total of 30 sessions per ten weeks. Comprehensive hand repetitive intensive strength training included treadmill training for the upper limb with body weight supporting the using upper limb. The posture of an arm swing was to maintain the joints of the elbows and wrist as much as possible, and the shoulder joint was allowed to be flexed by 160 degrees. |
| Routine Physical Therapy | Other | Other: Routine Physical Therapycontrol will received 60 minutes per a session, three sessions a week, at a total of 30 sessions per 10 weeks by creating a home program, which consisted of a total of 8 exercises that enhanced the muscular strength of the upper limb including the triceps brachii and extensor carpi radialis, and conveyed an effect of reaching the muscles out. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Ages 6 to 12 years will be included
- Both genders will be included
- GMFCS I and II
- Children who have normal communication skills and cognitive functions will be included
Key exclusion criteria (2 listed)
- Children having damage to the musculoskeletal system including fracture of the upper limb and contracture will be excluded
- Children who have undergone the administration of medicine influencing muscular strength and spasticity will be 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 |
|---|---|---|
| Intensive Strength TrainingComprehensive Hand Repetitive Intensive Strength Training and Routine Physical Therapy 60 minutes per session, three sessions a week, at a total of 30 sessions per ten weeks. Comprehensive hand repetitive intensive strength training included treadmill training for the upper limb with body weight supporting the using upper limb. The posture of an arm swing was to maintain the joints of the elbows and wrist as much as possible, and the shoulder joint was allowed to be flexed by 160 degrees .The posture of the arm stance supported the weight using metacarpal heads, hands, and elbows, and the shoulder joints were allowed to be flexed by 90 degrees. | Other | Experimental group will received Comprehensive Hand Repetitive Intensive Strength Training |
| Routine Physical TherapyReceived 60 minutes per a session, three sessions a week, at a total of 30 sessions per 10 weeks by creating a home program, which consisted of a total of 8 exercises that enhanced the muscular strength of the upper limb including the triceps brachii and extensor carpi radialis, and conveyed an effect of reaching the muscles out. flexion and extension muscle strengthening with towel, hand grip and wrist extension muscle strengthening This exercise consisted of shoulder extension muscle, elbow flexion muscle, shoulder abduction muscle, and elbow extension muscle strengthening with a thera band, as well as hand grip, forearm with a velcro board, wrist extension muscle strengthening with sandbag and shoulder abduction-extension muscle strengthening with a thera band. | Other | Routine Physical Therapy |
Primary outcome
Jebsen-Taylor Hand Function Test (JTHFT)
Time frame: 15 to 30 minutes
The Jebsen-Taylor Hand Function Test (JTHFT) is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL). The JTHFT has seven subsets which are writing, simulated page-turning, lifting small objects, stimulated tree feeding, stacking, and lifting large, lightweight, and heavy objects. [JTHFT finds easy applicability in clinical settings since it can be administered in a short time by using readily available materials. Several studies report that the JTHFT is a valid assessment tool for the measurement of hand dysfunctions from a variety of patient populations having high reliability were (0.84-0.94 )
ABIL HAND
Time frame: 10 - 20 minutes
ABILHAND-Kids Survey, which evaluates upper extremity function in children with cerebral palsy ABILHAND-Kids survey evaluates the bilateral upper extremities of children, and which has proven validity and reliability were 0.96 and 0.70 , including 21 questions for families related to the common tasks undertaken by their children in their daily living activities. The ABILHAND-Kids survey was originally developed in French as a standard means of assessment of manual ability in children with CP. This survey evaluates the most typical indicators of manual activity, in which some of the items were developed based on the ABILHAND-Kids survey, which was developed to assess manual ability in adult patients, while other items were selected from existing scales or were adapted to broaden the variability of activities
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 31514564Kara OK, Yardimci BN, Sahin S, Orhan C, Livanelioglu A, Soylu AR. Combined Effects of Mirror Therapy and Exercises on the Upper Extremities in Children with Unilateral Cerebral Palsy: A Randomized Controlled Trial. Dev Neurorehabil. 2020 May;23(4):253-264. doi: 10.1080/17518423.2019.1662853. Epub 2019 Sep 13.
- 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.
Nisha Feroz, MS principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Strength Training and Routine Physical Therapy in people with Cerebral Palsy (CP), run by Riphah International University at 2 sites in Pakistan.
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 2 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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad Dr, PhD (9233224390125, Imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jebsen-Taylor Hand Function Test (JTHFT) (time frame: 15 to 30 minutes). The study lists 2 primary outcomes in all. 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 NCT06748235, 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 27 Dec 2024.