Hemiplegic Cerebral PalsyNCT05380011
Bimanual Task Training and Constraint-Induced Movement Therapy in Hemiplegic Cerebral Palsy Children
A study testing Constraint Induced Movement Therapy and Bimanual Task Training and Bimanual Task Training in people with Hemiplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Various studies have been done comparing the individual effects of the two interventions of Constraint-Induced Movement Therapy and Bimanual Task Training in Hemiplegic Cerebral Palsy Children, but this study will compare the effects of combined interventions with a single intervention. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- Constraint Induced Movement Therapy and Bimanual Task Training and Bimanual Task Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 20 May 2022to 20 Nov 2022
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with both Gender (Male and Female).
- Age between 5 to 15 years.
- Hemiplegic Cerebral Palsy Children.
- Patients fulfilling the criteria of Constraint Induced Movement Therapy (CIMT) i.e. wrist extension 20 degree, MCP and IP extension 10 degree.
Who cannot join
- Hemiplegic Cerebral Palsy children due to Traumatic Brain Injury.
- Patients having cognitive impairments.
- Hemiplegic Cerebral Palsy children with rigid deformities of upper extremity.
- Patients having associated Neurological Pathologies.
- Patients who are unable to follow treatment plan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Bimanual Task Training With and Without Constraint-Induced Movement Therapy on Upper Limb Functions in Hemiplegic Cerebral Palsy Children
Various studies have been done comparing the individual effects of the two interventions of Constraint-Induced Movement Therapy and Bimanual Task Training in Hemiplegic Cerebral Palsy Children, but this study will compare the effects of combined interventions with a single intervention. This study will contribute to the upper motor function in hemiplegic cerebral palsy children i.e. manual dexterity, grasp and release function, quality and efficacy of movement, combined bimanual use of both hands and coordination, as a result of two intervention protocols.
Read the detailed description
Various studies have been done comparing the individual effects of these two interventions of Constraint-Induced Movement Therapy and Bimanual Task Training in Hemiplegic Cerebral Palsy Children. But the literature comparing the effects of combined interventions of these two with either of the single intervention is sparse and limited, utilizing different clinical experiences and tools for the respective study. This study will contribute to the upper motor function in hemiplegic cerebral palsy children by comparing the effects of combined interventions with a single intervention with its overall effects in the respective population i.e. manual dexterity, grasp and release function, quality and efficacy of movement, combined bimanual use of both hands and coordination, as a result of two intervention protocols. A total of 54 patients diagnosed with Hemiplegic Cerebral Palsy will be selected for data collection according to the inclusion criteria. Patients will be divided into two groups, Group A and Group B. Group A will receive Bimanual Task Training and Constraint-Induced Movement Therapy (CIMT) and Group B will receive Bimanual Task Training alone. Constraint-Induced Movement Therapy (CIMT) will be performed 1.5 hours daily, with the constraint of 6 hours applied daily, thrice-weekly sessions, with a total of 10 to 12 sessions, for 4 weeks, along with, Bimanual Task Training with the practice of each task for 15 to 30 minutes, 1.5 hours daily, thrice-weekly sessions, with a total of 10 to 12 sessions, for 4 weeks respectively in Group A, whereas, Bimanual Task Training will be performed with the practice of each task for 15 to 30 minutes, 1.5 hours daily, thrice-weekly sessions, with a total of 10 to 12 sessions, for 4 weeks in Group B. Data will be collected at baseline, at 2 weeks and at 4 weeks after intervention from both groups. Upper Limb Functions will be measured using the Melbourne Assessment of Unilateral Upper Limb Function (MUUL) and Canadian Occupational Performance Measure (COPM) and Quality of life will be measured using Cerebral Palsy Quality Of Life measure (CP-QOL).
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- Constraint Induced Movement Therapy and Bimanual Task Training, Bimanual Task Training
- Keywords
- Constraint Induced Movement Therapy, Bimanual Task Training, Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint Induced Movement Therapy and Bimanual Task TrainingOther
Constraint-Induced Movement Therapy and Bimanual Task Training will be performed. Constraint-Induced Movement Therapy has been shown to improve the uni-manual capacity of the impaired limb as well as improvement in quality and efficiency of movement and greater grasp function, whereas Bimanual Task Training has been shown to improve bimanual task performance, bilateral spontaneous use of affected limb and better bimanual coordination during daily life activities.
Bimanual Task TrainingOther
Bimanual Task Training will be performed. Bimanual Task Training has been shown to improve bimanual task performance, bilateral spontaneous use of affected limb and better bimanual coordination during daily life activities.
| Study group | Role | What they receive |
|---|---|---|
| Group A (CIMT and Bimanual Task Training) | Experimental | Constraint Induced Movement Therapy and Bimanual Task Training Receives: Other: Constraint Induced Movement Therapy and Bimanual Task Training |
| Group B (Bimanual Task Training) | Experimental | Bimanual Task Training Receives: Other: Bimanual Task Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
Melbourne Assessment of Unilateral Upper Limb Function (MUUL) is considered one of the reliable tools to measure upper limb function. It consists of 16-items to measure the quality of unilateral upper limb function. Items of the assessment involve reach, grasp, and release. It shows excellent construct and inter-rater validity as well as its shows good reliability for treatment planning and clinical decision making. It has a total 16 number of items. Scoring is completed for 37 item sub-scores using a three, four or five-point scale and individually defined scoring criteria for each item. The maximum score is 122 and the minimum score is 0, where higher scores reflect the greater quality of upper limb movement.
Measured: baseline
Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
Melbourne Assessment of Unilateral Upper Limb Function (MUUL) is considered one of the reliable tools to measure upper limb function. It consists of 16-items to measure the quality of unilateral upper limb function. Items of the assessment involve reach, grasp, and release. It shows excellent construct and inter-rater validity as well as its shows good reliability for treatment planning and clinical decision making. It has a total 16 number of items. Scoring is completed for 37 item sub-scores using a three, four or five-point scale and individually defined scoring criteria for each item. The maximum score is 122 and the minimum score is 0, where higher scores reflect the greater quality of upper limb movement.
Measured: 2 weeks
Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
Melbourne Assessment of Unilateral Upper Limb Function (MUUL) is considered one of the reliable tools to measure upper limb function. It consists of 16-items to measure the quality of unilateral upper limb function. Items of the assessment involve reach, grasp, and release. It shows excellent construct and inter-rater validity as well as its shows good reliability for treatment planning and clinical decision making. It has a total 16 number of items. Scoring is completed for 37 item sub-scores using a three, four or five-point scale and individually defined scoring criteria for each item. The maximum score is 122 and the minimum score is 0, where higher scores reflect the greater quality of upper limb movement.
Measured: 4 weeks
Canadian Occupation Performance Measure (COPM)
It is a client-centred outcome measure that helps the client to identify occupational performance issues and rates performance and satisfaction pre and post-intervention. This tool involves the first identification of problems or daily occupations of importance that are needed or expected to do, and then secondly, the client is asked to rate the importance of each occupation using a 10-point rating scale. In the third step. the client selects up to 5 most important problems to be addressed in intervention and the therapist enters the chosen problems and their importance ratings in the scoring section. In the fourth step, the client is asked to use a 10-point scale to rate their own level of performance and satisfaction with performance for 5 identified problems.
Measured: baseline
Canadian Occupation Performance Measure (COPM)
It is a client-centred outcome measure that helps the client to identify occupational performance issues and rates performance and satisfaction pre and post-intervention. This tool involves the first identification of problems or daily occupations of importance that are needed or expected to do, and then secondly, the client is asked to rate the importance of each occupation using a 10-point rating scale. In the third step. the client selects up to 5 most important problems to be addressed in intervention and the therapist enters the chosen problems and their importance ratings in the scoring section. In the fourth step, the client is asked to use a 10-point scale to rate their own level of performance and satisfaction with performance for 5 identified problems.
Measured: 2 weeks
Canadian Occupation Performance Measure (COPM)
It is a client-centred outcome measure that helps the client to identify occupational performance issues and rates performance and satisfaction pre and post-intervention. This tool involves the first identification of problems or daily occupations of importance that are needed or expected to do, and then secondly, the client is asked to rate the importance of each occupation using a 10-point rating scale. In the third step. the client selects up to 5 most important problems to be addressed in intervention and the therapist enters the chosen problems and their importance ratings in the scoring section. In the fourth step, the client is asked to use a 10-point scale to rate their own level of performance and satisfaction with performance for 5 identified problems.
Measured: 4 weeks
Cerebral Palsy Quality Of Life scale (CP-QOL)
The Cerebral Palsy (CP) Quality Of Life scale-child is a condition-specific Quality Of Life (QOL) questionnaire designed for children with CP.
Feasibility, sensitivity, Instrument validity and internal consistency of both self-and proxy-report questionnaires are good and are becoming a fundamental component of public health surveillance. QOL is broadly defined as a subjective multidimensional concept for assessing a person's wellbeing across numerous life indicators. The child self-report form contains 52 items and is divided into areas: well-being and social acceptance, functionality, participation and physical health, emotional well-being and self-esteem, access to services and pain and impact disability. All items are rated from 1 to 9, except for one item in the pain and impact disability domain, which is rated on a 5-point scale. All responses are then converted into scale scores between 0 to 100. Higher scores mean a higher quality of life and vice versa.
Measured: baseline
Cerebral Palsy Quality Of Life scale (CP-QOL)
The Cerebral Palsy (CP) Quality Of Life scale-child is a condition-specific Quality Of Life (QOL) questionnaire designed for children with CP.
Feasibility, sensitivity, Instrument validity and internal consistency of both self-and proxy-report questionnaires are good and are becoming a fundamental component of public health surveillance. QOL is broadly defined as a subjective multidimensional concept for assessing a person's wellbeing across numerous life indicators. The child self-report form contains 52 items and is divided into areas: well-being and social acceptance, functionality, participation and physical health, emotional well-being and self-esteem, access to services and pain and impact disability. All items are rated from 1 to 9, except for one item in the pain and impact disability domain, which is rated on a 5-point scale. All responses are then converted into scale scores between 0 to 100. Higher scores mean a higher quality of life and vice versa.
Measured: 2 weeks
Cerebral Palsy Quality Of Life scale (CP-QOL)
The Cerebral Palsy (CP) Quality Of Life scale-child is a condition-specific Quality Of Life (QOL) questionnaire designed for children with CP.
Feasibility, sensitivity, Instrument validity and internal consistency of both self-and proxy-report questionnaires are good and are becoming a fundamental component of public health surveillance. QOL is broadly defined as a subjective multidimensional concept for assessing a person's wellbeing across numerous life indicators. The child self-report form contains 52 items and is divided into areas: well-being and social acceptance, functionality, participation and physical health, emotional well-being and self-esteem, access to services and pain and impact disability. All items are rated from 1 to 9, except for one item in the pain and impact disability domain, which is rated on a 5-point scale. All responses are then converted into scale scores between 0 to 100. Higher scores mean a higher quality of life and vice versa.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start20 May 2022
- Primary completion20 Nov 2022
- Study completion20 Nov 2022
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.
- More trials run by Riphah International 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Amjad, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380011
- Sponsor's protocol ID
- REC/01263 Ayesha bint Ihsan
- Status last verified
- Nov 2022
- First submitted
- 13 May 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- 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 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bimanual Task Training With and Without Constraint-Induced Movement Therapy on Upper Limb Functions in Hemiplegic Cerebral Palsy Children
- ClinicalTrials.gov ID
- NCT05380011
- Acronym / sponsor ID
- REC/01263 Ayesha bint Ihsan
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- Constraint Induced Movement Therapy, Bimanual Task Training, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 18 May 2022 (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.
Various studies have been done comparing the individual effects of the two interventions of Constraint-Induced Movement Therapy and Bimanual Task Training in Hemiplegic Cerebral Palsy Children, but this study will compare the effects of combined interventions with a single intervention. This study will contribute to the upper motor function in hemiplegic cerebral palsy children i.e. manual dexterity, grasp and release function, quality and efficacy of movement, combined bimanual use of both hands and coordination, as a result of two intervention protocols.
Detailed description
Various studies have been done comparing the individual effects of these two interventions of Constraint-Induced Movement Therapy and Bimanual Task Training in Hemiplegic Cerebral Palsy Children. But the literature comparing the effects of combined interventions of these two with either of the single intervention is sparse and limited, utilizing different clinical experiences and tools for the respective study. This study will contribute to the upper motor function in hemiplegic cerebral palsy children by comparing the effects of combined interventions with a single intervention with its overall effects in the respective population i.e. manual dexterity, grasp and release function, quality and efficacy of movement, combined bimanual use of both hands and coordination, as a result of two intervention protocols. A total of 54 patients diagnosed with Hemiplegic Cerebral Palsy will be selected for data collection according to the inclusion criteria. Patients will be divided into two groups, Group A and Group B. Group A will receive Bimanual Task Training and Constraint-Induced Movement Therapy (CIMT) and Group B will receive Bimanual Task Training alone. Constraint-Induced Movement Therapy (CIMT) will be performed 1.5 hours daily, with the constraint of 6 hours applied daily, thrice-weekly sessions, with a total of 10 to 12 sessions, for 4 weeks, along with, Bimanual Task Training with the practice of each task for 15 to 30 minutes, 1.5 hours daily, thrice-weekly sessions, with a total of 10 to 12 sessions, for 4 weeks respectively in Group A, whereas, Bimanual Task Training will be performed with the practice of each task for 15 to 30 minutes, 1.5 hours daily, thrice-weekly sessions, with a total of 10 to 12 sessions, for 4 weeks in Group B. Data will be collected at baseline, at 2 weeks and at 4 weeks after intervention from both groups. Upper Limb Functions will be measured using the Melbourne Assessment of Unilateral Upper Limb Function (MUUL) and Canadian Occupational Performance Measure (COPM) and Quality of life will be measured using Cerebral Palsy Quality Of Life measure (CP-QOL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (CIMT and Bimanual Task Training) | Experimental | Other: Constraint Induced Movement Therapy and Bimanual Task TrainingConstraint Induced Movement Therapy and Bimanual Task Training |
| Group B (Bimanual Task Training) | Experimental | Other: Bimanual Task TrainingBimanual Task Training |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with both Gender (Male and Female).
- Age between 5 to 15 years.
- Hemiplegic Cerebral Palsy Children.
- Patients fulfilling the criteria of Constraint Induced Movement Therapy (CIMT) i.e. wrist extension 20 degree, MCP and IP extension 10 degree.
Key exclusion criteria (5 listed)
- Hemiplegic Cerebral Palsy children due to Traumatic Brain Injury.
- Patients having cognitive impairments.
- Hemiplegic Cerebral Palsy children with rigid deformities of upper extremity.
- Patients having associated Neurological Pathologies.
- Patients who are unable to follow treatment plan.
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 |
|---|---|---|
| Constraint Induced Movement Therapy and Bimanual Task TrainingConstraint-Induced Movement Therapy and Bimanual Task Training will be performed. Constraint-Induced Movement Therapy has been shown to improve the uni-manual capacity of the impaired limb as well as improvement in quality and efficiency of movement and greater grasp function, whereas Bimanual Task Training has been shown to improve bimanual task performance, bilateral spontaneous use of affected limb and better bimanual coordination during daily life activities. | Other | Group A (CIMT and Bimanual Task Training) |
| Bimanual Task TrainingBimanual Task Training will be performed. Bimanual Task Training has been shown to improve bimanual task performance, bilateral spontaneous use of affected limb and better bimanual coordination during daily life activities. | Other | Group B (Bimanual Task Training) |
Primary outcome
Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
Time frame: baseline
Melbourne Assessment of Unilateral Upper Limb Function (MUUL) is considered one of the reliable tools to measure upper limb function. It consists of 16-items to measure the quality of unilateral upper limb function. Items of the assessment involve reach, grasp, and release. It shows excellent construct and inter-rater validity as well as its shows good reliability for treatment planning and clinical decision making. It has a total 16 number of items. Scoring is completed for 37 item sub-scores using a three, four or five-point scale and individually defined scoring criteria for each item. The maximum score is 122 and the minimum score is 0, where higher scores reflect the greater quality of upper limb movement.
Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
Time frame: 2 weeks
Melbourne Assessment of Unilateral Upper Limb Function (MUUL) is considered one of the reliable tools to measure upper limb function. It consists of 16-items to measure the quality of unilateral upper limb function. Items of the assessment involve reach, grasp, and release. It shows excellent construct and inter-rater validity as well as its shows good reliability for treatment planning and clinical decision making. It has a total 16 number of items. Scoring is completed for 37 item sub-scores using a three, four or five-point scale and individually defined scoring criteria for each item. The maximum score is 122 and the minimum score is 0, where higher scores reflect the greater quality of upper limb movement.
Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
Time frame: 4 weeks
Melbourne Assessment of Unilateral Upper Limb Function (MUUL) is considered one of the reliable tools to measure upper limb function. It consists of 16-items to measure the quality of unilateral upper limb function. Items of the assessment involve reach, grasp, and release. It shows excellent construct and inter-rater validity as well as its shows good reliability for treatment planning and clinical decision making. It has a total 16 number of items. Scoring is completed for 37 item sub-scores using a three, four or five-point scale and individually defined scoring criteria for each item. The maximum score is 122 and the minimum score is 0, where higher scores reflect the greater quality of upper limb movement.
Canadian Occupation Performance Measure (COPM)
Time frame: baseline
It is a client-centred outcome measure that helps the client to identify occupational performance issues and rates performance and satisfaction pre and post-intervention. This tool involves the first identification of problems or daily occupations of importance that are needed or expected to do, and then secondly, the client is asked to rate the importance of each occupation using a 10-point rating scale. In the third step. the client selects up to 5 most important problems to be addressed in intervention and the therapist enters the chosen problems and their importance ratings in the scoring section. In the fourth step, the client is asked to use a 10-point scale to rate their own level of performance and satisfaction with performance for 5 identified problems.
Canadian Occupation Performance Measure (COPM)
Time frame: 2 weeks
It is a client-centred outcome measure that helps the client to identify occupational performance issues and rates performance and satisfaction pre and post-intervention. This tool involves the first identification of problems or daily occupations of importance that are needed or expected to do, and then secondly, the client is asked to rate the importance of each occupation using a 10-point rating scale. In the third step. the client selects up to 5 most important problems to be addressed in intervention and the therapist enters the chosen problems and their importance ratings in the scoring section. In the fourth step, the client is asked to use a 10-point scale to rate their own level of performance and satisfaction with performance for 5 identified problems.
Canadian Occupation Performance Measure (COPM)
Time frame: 4 weeks
It is a client-centred outcome measure that helps the client to identify occupational performance issues and rates performance and satisfaction pre and post-intervention. This tool involves the first identification of problems or daily occupations of importance that are needed or expected to do, and then secondly, the client is asked to rate the importance of each occupation using a 10-point rating scale. In the third step. the client selects up to 5 most important problems to be addressed in intervention and the therapist enters the chosen problems and their importance ratings in the scoring section. In the fourth step, the client is asked to use a 10-point scale to rate their own level of performance and satisfaction with performance for 5 identified problems.
Cerebral Palsy Quality Of Life scale (CP-QOL)
Time frame: baseline
The Cerebral Palsy (CP) Quality Of Life scale-child is a condition-specific Quality Of Life (QOL) questionnaire designed for children with CP. Feasibility, sensitivity, Instrument validity and internal consistency of both self-and proxy-report questionnaires are good and are becoming a fundamental component of public health surveillance. QOL is broadly defined as a subjective multidimensional concept for assessing a person's wellbeing across numerous life indicators. The child self-report form contains 52 items and is divided into areas: well-being and social acceptance, functionality, participation and physical health, emotional well-being and self-esteem, access to services and pain and impact disability. All items are rated from 1 to 9, except for one item in the pain and impact disability domain, which is rated on a 5-point scale. All responses are then converted into scale scores between 0 to 100. Higher scores mean a higher quality of life and vice versa.
Cerebral Palsy Quality Of Life scale (CP-QOL)
Time frame: 2 weeks
The Cerebral Palsy (CP) Quality Of Life scale-child is a condition-specific Quality Of Life (QOL) questionnaire designed for children with CP. Feasibility, sensitivity, Instrument validity and internal consistency of both self-and proxy-report questionnaires are good and are becoming a fundamental component of public health surveillance. QOL is broadly defined as a subjective multidimensional concept for assessing a person's wellbeing across numerous life indicators. The child self-report form contains 52 items and is divided into areas: well-being and social acceptance, functionality, participation and physical health, emotional well-being and self-esteem, access to services and pain and impact disability. All items are rated from 1 to 9, except for one item in the pain and impact disability domain, which is rated on a 5-point scale. All responses are then converted into scale scores between 0 to 100. Higher scores mean a higher quality of life and vice versa.
Cerebral Palsy Quality Of Life scale (CP-QOL)
Time frame: 4 weeks
The Cerebral Palsy (CP) Quality Of Life scale-child is a condition-specific Quality Of Life (QOL) questionnaire designed for children with CP. Feasibility, sensitivity, Instrument validity and internal consistency of both self-and proxy-report questionnaires are good and are becoming a fundamental component of public health surveillance. QOL is broadly defined as a subjective multidimensional concept for assessing a person's wellbeing across numerous life indicators. The child self-report form contains 52 items and is divided into areas: well-being and social acceptance, functionality, participation and physical health, emotional well-being and self-esteem, access to services and pain and impact disability. All items are rated from 1 to 9, except for one item in the pain and impact disability domain, which is rated on a 5-point scale. All responses are then converted into scale scores between 0 to 100. Higher scores mean a higher quality of life and vice versa.
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 28 Nov 2022.
- 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.
Imran Amjad, PhD principal investigator
Riphah International 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 Constraint Induced Movement Therapy and Bimanual Task Training and Bimanual Task Training in people with Hemiplegic Cerebral Palsy, run by Riphah International University at 1 site 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 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 28 Nov 2022. 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 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?
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?
Melbourne Assessment of Unilateral Upper Limb Function (MUUL) (time frame: baseline). The study lists 9 primary outcomes in all. 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 28 Nov 2022.