Hemiplegic Cerebral PalsyNCT06846190
Modified Constraint Induced Movement Therapy Versus Virtual Reality Training in Children With Cerebral Palsy
A study testing mCIMT and VR in people with Hemiplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Children with hemiplegic cerebral palsy (CP) are characterized by motor impairments mainly lateralized to one side of the body, with greater upper limb than lower limb involvement; these impairments may further limit the daily activities and school participation of children with hemiplegic CP. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- mCIMT and VR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2025to 31 Jul 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
- Age range between 5 to 16 years of age.
- Medical diagnosis of spastic hemiparetic CP.
- At least 20◦wrist and 10◦ active finger extension from full flexion.
- More movement deficits in 1 upper extremity (less than 2.5 on the Amount of Use scale (AOU) on the Pediatric Motor Activity Log (PMAL)).
- Muscle tone less than 3 on the Modified Ashworth Scale.
- Normal or corrected-to-normal vision and hearing.
- Classified level I, II, or III of the Manual Ability Classification System ( MACS) for Children with CP
Who cannot join
- Health problems not associated with CP.
- Seizure hemispatial neglect.
- Orthopaedic surgery on the involved upper extremity.
- Botulinum toxin therapy for the affected upper extremity within the past 6 months or within the study period.
- Balance problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Rising Sun Institute
Lahore, Punjab Province, 54900
Muhammad Asif Javed, MS-PT(Neuro), 923224209422, a.javed@riphah.edu.pk
About this study
Official title: Effects of Modified Constraint Induced Movement Therapy Versus Virtual Reality Training in Children With Hemiplegic Cerebral Palsy
Children with hemiplegic cerebral palsy (CP) are characterized by motor impairments mainly lateralized to one side of the body, with greater upper limb than lower limb involvement; these impairments may further limit the daily activities and school participation of children with hemiplegic CP. For the improvement of activity limitations in hemipelagic cerebral palsy children will take 20 hemiplegic cerebral palsy children with the age of 5-16 year all participants will be randomly assign and use modified Constraint induced movement therapy and virtual reality techniques.
mCIMT and Hot pack will be given to group I and unaffected hand will immobilized by a volar resting splint extending from finger tips to the proximal forearm. Use splint every day for at least 5 waking hours individualized, 18-hour program of mCIMT every other day, 3 times per week during a 4-week period. Each modified CIMT session continued for 1.5 hours will give to group I on the other hand VR and Hot pack will give to group II and 18-hour VR program, every other day, 3 times per week for 4 weeks will give Each VR session continued for 1.5 hours. Then evaluate both groups on follow up.
Read more
All the data will be collected from Rising Sun Institute by using ABILHAND-KIDS questionnaire and Children's hand-use experience questionnaire. The reliability and validity of tools and mentioned.
The duration of study will be 6-months. Data will be analyzed with the help of SPSS 27
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- mCIMT, VR
- Keywords
- Cerebral palsy, Hemiplegic, Modified constraint induced movement therapy, Spastic, Virtual reality
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mCIMTOther
mCIMT+ Hot pack will be applied and unaffected hand will be immobilized by a volar resting splint extending from finger tips to the proximal forearm. Use splint every day for at least 5 waking hours daily for 4 weeks and perform daily activities. Program of mCIMT every other day, 3 times per week during a 4-week period.
VROther
VR+ Hot pack will be applied. 25 minutes of VR program, every other day, 3 times per week for 4 weeks. Each VR session continued for 10 minutes then 5 minutes rest after that again 10 minutes VR session will do.
| Study group | Role | What they receive |
|---|---|---|
| mCIMT group | Experimental | Clinical experimental: For group -I mCIMT at least 5 waking hours daily for 4 weeks 3 times per week during a 4-week period. Receives: Other: mCIMT |
| VR Group | Active comparator | Clinical experimental: For group -II VR 25 minutes of VR program, every other day, 3 times per week for 4 weeks. Receives: Other: VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
CHEQ (Children's hand-use experience questionnaire)
CHEQ has been developed to capture children's perceived quality of performance when using the affected hand in these situations. CHEQ is an internet-based questionnaire containing 29 items (bimanual activities) presented one by one in random order. Test-retest reliability for the three CHEQ scale was: grasp efficacy, ICC=0.91; time taken, ICC=0.88; and feeling bothered, ICC=0.91. Total Maximum score of each component (quality, duration \& psycho-status) was 100 and total maximum score of hand use was 27. Higher the results showed improvement in hand function
Measured: Baseline, 4th week and 8th week
ABILHAND-KIDS questionnaire
ABILHAND-KIDS questionnaire is a valuable tool to assess a child's unimanual and bimanual upper limb activities. The reliability of the ABILHANDS-Kids is good across different observers as a performance- and capacity-based rating method. Test-retest reliability was 0.92. Total Maximum score was 42, mid score was 21 and minimum score was 0. Higher scores showed improvement in activity level of hand use
Measured: Baseline, 4th week and 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start15 Feb 2025
- Primary completion15 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized clinical trial performed, in which 20 hCP children with the age of 5-16 years will be taken randomly after screening and meeting inclusion criteria. Children will be divided in two groups. Group 1 will receive mCIMT for 5 hours in a day with alternating 3 days a week. Group 2 will receive VR for 25 min in a day with alternating 3 days a week. Pre values were taken at 1st week and then after 4th week mid values of interventions will be taken and post values of intervention will be taken after 8th week of intervention to measure the effects of both therapies.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Amjad, MS-PPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846190
- Sponsor's protocol ID
- REC/RCR/AHS/22/maria amjad
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roberts H, Shierk A, Clegg NJ, Baldwin D, Smith L, Yeatts P, Delgado MR. Constraint Induced Movement Therapy Camp for Children with Hemiplegic Cerebral Palsy Augmented by Use of an Exoskeleton to Play Games in Virtual Reality. Phys Occup Ther Pediatr. 2021;41(2):150-165. doi: 10.1080/01942638.2020.1812790. Epub 2020 Sep 7.
PubMed 32892679Wu J, Loprinzi PD, Ren Z. The Rehabilitative Effects of Virtual Reality Games on Balance Performance among Children with Cerebral Palsy: A Meta-Analysis of Randomized Controlled Trials. Int J Environ Res Public Health. 2019 Oct 28;16(21):4161. doi: 10.3390/ijerph16214161.
PubMed 31661938Aran OT, Sahin S, Kose B, Agce ZB, Kayihan H. Effectiveness of the virtual reality on cognitive function of children with hemiplegic cerebral palsy: a single-blind randomized controlled trial. Int J Rehabil Res. 2020 Mar;43(1):12-19. doi: 10.1097/MRR.0000000000000378.
PubMed 31658111Simon-Martinez C, Mailleux L, Ortibus E, Fehrenbach A, Sgandurra G, Cioni G, Desloovere K, Wenderoth N, Demaerel P, Sunaert S, Molenaers G, Feys H, Klingels K. Combining constraint-induced movement therapy and action-observation training in children with unilateral cerebral palsy: a randomized controlled trial. BMC Pediatr. 2018 Jul 31;18(1):250. doi: 10.1186/s12887-018-1228-2.
PubMed 30064396Harb A, Margetis K, Kishner S. Modified Ashworth Scale. 2025 Apr 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554572/
PubMed 32119459
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Modified Constraint Induced Movement Therapy Versus Virtual Reality Training in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06846190
- Acronym / sponsor ID
- REC/RCR/AHS/22/maria amjad
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- Cerebral palsy, Hemiplegic, Modified constraint induced movement therapy, Spastic, Virtual reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 25 Feb 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.
Children with hemiplegic cerebral palsy (CP) are characterized by motor impairments mainly lateralized to one side of the body, with greater upper limb than lower limb involvement; these impairments may further limit the daily activities and school participation of children with hemiplegic CP. For the improvement of activity limitations in hemipelagic cerebral palsy children will take 20 hemiplegic cerebral palsy children with the age of 5-16 year all participants will be randomly assign and use modified Constraint induced movement therapy and virtual reality techniques.
mCIMT and Hot pack will be given to group I and unaffected hand will immobilized by a volar resting splint extending from finger tips to the proximal forearm. Use splint every day for at least 5 waking hours individualized, 18-hour program of mCIMT every other day, 3 times per week during a 4-week period. Each modified CIMT session continued for 1.5 hours will give to group I on the other hand VR and Hot pack will give to group II and 18-hour VR program, every other day, 3 times per week for 4 weeks will give Each VR session continued for 1.5 hours. Then evaluate both groups on follow up.
All the data will be collected from Rising Sun Institute by using ABILHAND-KIDS questionnaire and Children's hand-use experience questionnaire. The reliability and validity of tools and mentioned.
The duration of study will be 6-months. Data will be analyzed with the help of SPSS 27
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A Randomized clinical trial performed, in which 20 hCP children with the age of 5-16 years will be taken randomly after screening and meeting inclusion criteria. Children will be divided in two groups. Group 1 will receive mCIMT for 5 hours in a day with alternating 3 days a week. Group 2 will receive VR for 25 min in a day with alternating 3 days a week. Pre values were taken at 1st week and then after 4th week mid values of interventions will be taken and post values of intervention will be taken after 8th week of intervention to measure the effects of both therapies.
| Arm | Type | Receives |
|---|---|---|
| mCIMT group | Experimental | Other: mCIMTClinical experimental: For group -I mCIMT at least 5 waking hours daily for 4 weeks 3 times per week during a 4-week period. |
| VR Group | Active comparator | Other: VRClinical experimental: For group -II VR 25 minutes of VR program, every other day, 3 times per week for 4 weeks. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age range between 5 to 16 years of age.
- Medical diagnosis of spastic hemiparetic CP.
- At least 20◦wrist and 10◦ active finger extension from full flexion.
- More movement deficits in 1 upper extremity (less than 2.5 on the Amount of Use scale (AOU) on the Pediatric Motor Activity Log (PMAL)).
- Muscle tone less than 3 on the Modified Ashworth Scale.
Key exclusion criteria (5 listed)
- Health problems not associated with CP.
- Seizure hemispatial neglect.
- Orthopaedic surgery on the involved upper extremity.
- Botulinum toxin therapy for the affected upper extremity within the past 6 months or within the study period.
- Balance problems
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 |
|---|---|---|
| mCIMTmCIMT+ Hot pack will be applied and unaffected hand will be immobilized by a volar resting splint extending from finger tips to the proximal forearm. Use splint every day for at least 5 waking hours daily for 4 weeks and perform daily activities. Program of mCIMT every other day, 3 times per week during a 4-week period. | Other | mCIMT group |
| VRVR+ Hot pack will be applied. 25 minutes of VR program, every other day, 3 times per week for 4 weeks. Each VR session continued for 10 minutes then 5 minutes rest after that again 10 minutes VR session will do. | Other | VR Group |
Primary outcome
CHEQ (Children's hand-use experience questionnaire)
Time frame: Baseline, 4th week and 8th week
CHEQ has been developed to capture children's perceived quality of performance when using the affected hand in these situations. CHEQ is an internet-based questionnaire containing 29 items (bimanual activities) presented one by one in random order. Test-retest reliability for the three CHEQ scale was: grasp efficacy, ICC=0.91; time taken, ICC=0.88; and feeling bothered, ICC=0.91. Total Maximum score of each component (quality, duration \& psycho-status) was 100 and total maximum score of hand use was 27. Higher the results showed improvement in hand function
ABILHAND-KIDS questionnaire
Time frame: Baseline, 4th week and 8th week
ABILHAND-KIDS questionnaire is a valuable tool to assess a child's unimanual and bimanual upper limb activities. The reliability of the ABILHANDS-Kids is good across different observers as a performance- and capacity-based rating method. Test-retest reliability was 0.92. Total Maximum score was 42, mid score was 21 and minimum score was 0. Higher scores showed improvement in activity level of hand use
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 25 Feb 2025.
- Background: PubMed 32892679Roberts H, Shierk A, Clegg NJ, Baldwin D, Smith L, Yeatts P, Delgado MR. Constraint Induced Movement Therapy Camp for Children with Hemiplegic Cerebral Palsy Augmented by Use of an Exoskeleton to Play Games in Virtual Reality. Phys Occup Ther Pediatr. 2021;41(2):150-165. doi: 10.1080/01942638.2020.1812790. Epub 2020 Sep 7.
- Background: PubMed 31661938Wu J, Loprinzi PD, Ren Z. The Rehabilitative Effects of Virtual Reality Games on Balance Performance among Children with Cerebral Palsy: A Meta-Analysis of Randomized Controlled Trials. Int J Environ Res Public Health. 2019 Oct 28;16(21):4161. doi: 10.3390/ijerph16214161.
- Background: PubMed 31658111Aran OT, Sahin S, Kose B, Agce ZB, Kayihan H. Effectiveness of the virtual reality on cognitive function of children with hemiplegic cerebral palsy: a single-blind randomized controlled trial. Int J Rehabil Res. 2020 Mar;43(1):12-19. doi: 10.1097/MRR.0000000000000378.
- Background: PubMed 30064396Simon-Martinez C, Mailleux L, Ortibus E, Fehrenbach A, Sgandurra G, Cioni G, Desloovere K, Wenderoth N, Demaerel P, Sunaert S, Molenaers G, Feys H, Klingels K. Combining constraint-induced movement therapy and action-observation training in children with unilateral cerebral palsy: a randomized controlled trial. BMC Pediatr. 2018 Jul 31;18(1):250. doi: 10.1186/s12887-018-1228-2.
- Background: PubMed 32119459Harb A, Margetis K, Kishner S. Modified Ashworth Scale. 2025 Apr 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554572/
- 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.
Maria Amjad, MS-PPT 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 mCIMT and VR 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 7 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: looking for participants now, as of the sponsor's last update on 25 Feb 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 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, 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?
CHEQ (Children's hand-use experience questionnaire) (time frame: Baseline, 4th week and 8th week). 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 NCT06846190, which also lists 5 linked publications.
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 25 Feb 2025; AzTrials last refreshed its copy on 3 Nov 2026.