Spastic Hemiplegic Cerebral PalsyNCT07747974
Effectiveness of Modified Constraint-Induced Movement Therapy Versus Mirror Therapy in Spastic Hemiplegic Cerebral Palsy Children
A study testing Experimental in people with Spastic Hemiplegic Cerebral Palsy, run by Ibadat International University, Islamabad at 1 site in Pakistan.
Trial summary
This randomized controlled trial was conducted to compare the effectiveness of Modified Constraint-Induced Movement Therapy (MCIMT) and Mirror Therapy in improving upper limb function among children with spastic hemiplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Spastic Hemiplegic Cerebral Palsy
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Mar 2026to 30 Sep 2026
- 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 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5-9 years.
- Male and female participants.
- Diagnosed with spastic hemiplegic cerebral palsy.
- Modified Ashworth Scale Grade 1 or 1+.
- Able to understand and follow verbal commands.
Who cannot join
- Severe fixed hand deformity.
- Cognitive impairment.
- Severe visual impairment.
- Uncontrolled seizures.
- Previous upper limb surgery.
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
Ibadat International University
Islamabad, 4700
Hafsah Arshad, PhD*, 03315165234, hafsah.arshad@uipt.iiui.edu.pk
Laiba Khushbakht, MS (Paeds)
About this study
Official title: A Randomized Controlled Trial to Compare the Effectiveness of Modified Constraint-Induced Movement Therapy Versus Mirror Therapy on Grip Strength, Manual Dexterity, and Spasticity in Children With Spastic Hemiplegic Cerebral Palsy
This randomized controlled trial was conducted to compare the effectiveness of Modified Constraint-Induced Movement Therapy (MCIMT) and Mirror Therapy in improving upper limb function among children with spastic hemiplegic cerebral palsy. Upper limb dysfunction, including reduced grip strength, impaired manual dexterity, and increased spasticity, limits functional independence and participation in daily activities in these children. Although both interventions are widely used in pediatric rehabilitation, direct comparative evidence remains limited.
A total of 42 children aged 5-9 years diagnosed with spastic hemiplegic cerebral palsy were recruited from Akbar Kare Institute and Comprehensive Physical Rehabilitation Center, Peshawar. Participants were selected through convenience sampling and randomly allocated into two equal groups using the sealed envelope method. Group A received Modified Constraint-Induced Movement Therapy, while Group B received Mirror Therapy. Both groups received treatment for 30 minutes per session, five sessions per week, for six consecutive weeks.
Grip strength was assessed using the Hand-Held Dynamometer, manual dexterity using the Box and Block Test, and spasticity using the Modified Ashworth Scale. The findings of this study provide evidence regarding the comparative effectiveness of these two rehabilitation approaches and may assist clinicians in selecting the most appropriate intervention for improving upper limb function in children with spastic hemiplegic cerebral palsy.
Read the detailed description
This study employed a parallel-group randomized controlled trial design to evaluate the comparative effectiveness of Modified Constraint-Induced Movement Therapy and Mirror Therapy. Following ethical approval, eligible participants were recruited according to predefined inclusion and exclusion criteria. After obtaining informed consent from parents or guardians, baseline assessments were performed.
Participants were randomly assigned to one of two intervention groups. Both groups received standardized treatment sessions lasting 30 minutes, five days per week for six weeks. Outcome measures included grip strength measured with a Hand-Held Dynamometer, manual dexterity measured using the Box and Block Test, and spasticity measured using the Modified Ashworth Scale. Assessments were conducted before and after completion of the intervention period. Statistical analysis was performed using SPSS Version 26 with a significance level of p < 0.05.
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Being tested
- Experimental, Control
- Keywords
- cerebral palsy, upper extremity rehabilitation, mirror therapy, manual dexterity, hand strength, Constraint-Induced Movement Therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Participants received MCIMT for 30 minutes per session, five sessions per week for six weeks, together with conventional physiotherapy.
ControlOther
Participants received Mirror Therapy for 30 minutes per session, five sessions per week for six weeks, together with conventional physiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Modified Constraint-Induced Movement Therapy | Experimental | Participants received MCIMT for 30 minutes per session, five sessions per week for six weeks, together with conventional physiotherapy. Receives: Other: Experimental |
| Mirror Therapy | Active comparator | Participants received Mirror Therapy for 30 minutes per session, five sessions per week for six weeks, together with conventional physiotherapy. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip Strength
Instrument: Hand-Held Dynamometer
Measured: Assessment Time: Baseline and 6 Weeks
Secondary outcomes (2)
Manual Dexterity
Instrument: Box and Block Test Box and Block Test measures unilateral gross manual dexterity. A patient sits at a table and moves as many 2.5 cm wooden blocks as possible one by one from one compartment of a divided box to the other within a 60-second time limit.
Measured: Assessment Time: Baseline and 6 Weeks
Spasticity
Instrument: Modified Ashworth Scale The Modified Ashworth Scale (MAS) is a clinical 6-point grading system used to measure increased muscle tone or spasticity by assessing resistance during passive soft tissue stretching.
Measured: Assessment Time: Baseline and 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start3 Mar 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic 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
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ibadat International University, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafsah Arshad, Ibadat International University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747974
- Sponsor's protocol ID
- IIUI/RERC/ADT/2026/02/258
- Status last verified
- Jun 2026
- First submitted
- 31 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Compare the Effectiveness of Modified Constraint-Induced Movement Therapy Versus Mirror Therapy on Grip Strength, Manual Dexterity, and Spasticity in Children With Spastic Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07747974
- Acronym / sponsor ID
- IIUI/RERC/ADT/2026/02/258
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Keywords
- cerebral palsy, upper extremity rehabilitation, mirror therapy, manual dexterity, hand strength, Constraint-Induced Movement Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ibadat International University, IslamabadUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 5 Aug 2026 (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.
This randomized controlled trial was conducted to compare the effectiveness of Modified Constraint-Induced Movement Therapy (MCIMT) and Mirror Therapy in improving upper limb function among children with spastic hemiplegic cerebral palsy. Upper limb dysfunction, including reduced grip strength, impaired manual dexterity, and increased spasticity, limits functional independence and participation in daily activities in these children. Although both interventions are widely used in pediatric rehabilitation, direct comparative evidence remains limited.
A total of 42 children aged 5-9 years diagnosed with spastic hemiplegic cerebral palsy were recruited from Akbar Kare Institute and Comprehensive Physical Rehabilitation Center, Peshawar. Participants were selected through convenience sampling and randomly allocated into two equal groups using the sealed envelope method. Group A received Modified Constraint-Induced Movement Therapy, while Group B received Mirror Therapy. Both groups received treatment for 30 minutes per session, five sessions per week, for six consecutive weeks.
Grip strength was assessed using the Hand-Held Dynamometer, manual dexterity using the Box and Block Test, and spasticity using the Modified Ashworth Scale. The findings of this study provide evidence regarding the comparative effectiveness of these two rehabilitation approaches and may assist clinicians in selecting the most appropriate intervention for improving upper limb function in children with spastic hemiplegic cerebral palsy.
Detailed description
This study employed a parallel-group randomized controlled trial design to evaluate the comparative effectiveness of Modified Constraint-Induced Movement Therapy and Mirror Therapy. Following ethical approval, eligible participants were recruited according to predefined inclusion and exclusion criteria. After obtaining informed consent from parents or guardians, baseline assessments were performed.
Participants were randomly assigned to one of two intervention groups. Both groups received standardized treatment sessions lasting 30 minutes, five days per week for six weeks. Outcome measures included grip strength measured with a Hand-Held Dynamometer, manual dexterity measured using the Box and Block Test, and spasticity measured using the Modified Ashworth Scale. Assessments were conducted before and after completion of the intervention period. Statistical analysis was performed using SPSS Version 26 with a significance level of p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Constraint-Induced Movement Therapy | Experimental | Other: ExperimentalParticipants received MCIMT for 30 minutes per session, five sessions per week for six weeks, together with conventional physiotherapy. |
| Mirror Therapy | Active comparator | Other: ControlParticipants received Mirror Therapy for 30 minutes per session, five sessions per week for six weeks, together with conventional physiotherapy. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 5-9 years.
- Male and female participants.
- Diagnosed with spastic hemiplegic cerebral palsy.
- Modified Ashworth Scale Grade 1 or 1+.
- Able to understand and follow verbal commands.
Key exclusion criteria (5 listed)
- Severe fixed hand deformity.
- Cognitive impairment.
- Severe visual impairment.
- Uncontrolled seizures.
- Previous upper limb surgery.
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 |
|---|---|---|
| ExperimentalParticipants received MCIMT for 30 minutes per session, five sessions per week for six weeks, together with conventional physiotherapy. | Other | Modified Constraint-Induced Movement Therapy |
| ControlParticipants received Mirror Therapy for 30 minutes per session, five sessions per week for six weeks, together with conventional physiotherapy. | Other | Mirror Therapy |
Primary outcome
Grip Strength
Time frame: Assessment Time: Baseline and 6 Weeks
Instrument: Hand-Held Dynamometer
2 secondary outcomes
Manual Dexterity
Time frame: Assessment Time: Baseline and 6 Weeks
Spasticity
Time frame: Assessment Time: Baseline and 6 Weeks
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 10 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Spastic Hemiplegic Cerebral Palsy
Not yet recruiting
Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
Active, not recruiting
Virtual Reality Vs Postural Control Training in Children With Cerebral Palsy
Children With Hemiplegic cp
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
Not yet recruiting
Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy.
Cerebral Palsy Spastic Hemiplegic, Functionnal Neurological Disorder
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Spastic Hemiplegic Cerebral Palsy, run by Ibadat International University, Islamabad 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 5 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 10 Aug 2026. 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 Hafsah Arshad, Phd* (03315165234, hafsah.arshad@uipt.iiui.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip Strength (time frame: Assessment Time: Baseline and 6 Weeks). 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 10 Aug 2026.