Cerebral Palsy (CP)CIMT-FES-CPNCT07587476
Constraint-induced Movement Therapy Combined With Functional Electrical Stimulation in Children With Cerebral Palsy
A study testing Constraint-Induced Movement Therapy Combined with Functional Electrical Stimulation and Constraint-Induced Movement Therapy in people with Cerebral Palsy (CP), run by Montiha Azeem at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to compare the effectiveness of Constraint-Induced Movement Therapy (CIMT) combined with Functional Electrical Stimulation (FES) versus CIMT alone in improving upper limb function, reducing spasticity, and enhancing functional independence in children with cerebral palsy (CP). Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Constraint-Induced Movement Therapy Combined with Functional Electrical Stimulation and Constraint-Induced Movement Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 18 May 2026to 29 Jun 2026
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 to 15 years, including both male and female population. Diagnosed with cerebral palsy (CP), confirmed by medical assessment and clinical evaluation.
- Moderate to severe impairment in upper limb function (as determined by a relevant motor function assessment scale, e.g., the Modified Ashworth Scale.
- Children with spastic and dyskinetic types of cerebral palsy. Children with cognitive ability that allows for participation in therapy, as determined by minimental status examination.
- No history of recent interventions (e.g., surgery, Botox injections) that may interfere with study participation.
Who cannot join
- Children with contraindications to functional electrical stimulation (e.g., pacemaker, skin conditions, or open wounds in the area of electrode placement).
- Presence of other significant neurological or musculoskeletal disorders that could confound the results (e.g., traumatic brain injury, muscular dystrophy)
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled trial aims to compare the effectiveness of Constraint-Induced Movement Therapy (CIMT) combined with Functional Electrical Stimulation (FES) versus CIMT alone in improving upper limb function, reducing spasticity, and enhancing functional independence in children with cerebral palsy (CP). A total of 46 children aged 3 to 15 years with spastic or dyskinetic cerebral palsy will be recruited from rehabilitation centers and hospitals in Sukkur, Pakistan. Participants will be randomly assigned into two groups: Group A will receive CIMT combined with FES, while Group B will receive CIMT alone. Both groups will undergo supervised therapy sessions five times per week for six weeks. Outcomes will be assessed before and after treatment using the Modified Ashworth Scale (MAS), Melbourne Assessment of Unilateral Upper Limb Function (MUUL), and Pediatric Evaluation of Disability Inventory (PEDI). The study aims to determine whether combining FES with CIMT provides greater improvements in motor recovery and daily functional performance in children with CP.
Read the detailed description
Cerebral palsy (CP) is one of the most common neurological disorders in children and is frequently associated with impaired upper limb function, spasticity, reduced motor control, and limitations in performing activities of daily living. Children with spastic and dyskinetic CP often experience difficulty in reaching, grasping, releasing, and manipulating objects, which negatively affects their independence and participation in daily activities. Various rehabilitation approaches have been developed to improve upper limb performance in children with CP, among which Constraint-Induced Movement Therapy (CIMT) has shown promising results in promoting cortical reorganization and functional use of the affected extremity.
CIMT is based on restraining the less affected upper limb to encourage intensive use of the affected limb through repetitive and task-oriented activities. Although CIMT has demonstrated effectiveness in improving motor outcomes, some children still exhibit limited voluntary muscle activation and persistent spasticity that may reduce the overall effectiveness of therapy. Functional Electrical Stimulation (FES) has emerged as an adjunctive rehabilitation technique that may facilitate neuromuscular activation, improve motor learning, and enhance voluntary movement by delivering low-level electrical impulses to targeted muscles.
The present study is designed to investigate the comparative effectiveness of CIMT combined with FES versus CIMT alone in children with cerebral palsy. The study will focus on evaluating changes in spasticity, upper limb function, and functional independence following a six-week intervention program. Participants will be randomly assigned into two treatment groups. Group A will receive CIMT combined with FES, while Group B will receive CIMT alone. Both groups will receive therapy sessions five times per week under the supervision of trained physiotherapists.
Outcome measures will include the Modified Ashworth Scale (MAS) for assessment of spasticity, the Melbourne Assessment of Unilateral Upper Limb Function (MUUL) for evaluation of upper limb motor performance, and the Pediatric Evaluation of Disability Inventory (PEDI) for assessment of functional independence. Assessments will be conducted before and after the intervention period to determine treatment effectiveness.
The findings of this study may contribute to evidence-based pediatric neurorehabilitation by identifying whether the addition of FES to CIMT provides superior therapeutic benefits compared to CIMT alone. The study may also help clinicians develop more effective rehabilitation protocols aimed at improving motor recovery, independence, and quality of life in children with cerebral palsy.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Constraint-Induced Movement Therapy Combined with Functional Electrical Stimulation, Constraint-Induced Movement Therapy
- Keywords
- Constraint-Induced Movement Therapy, Functional Electrical Stimulation (FES), Upper Limb Rehabilitation, Spasticity
- 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.
Constraint-Induced Movement Therapy Combined with Functional Electrical StimulationProcedure or surgery
This intervention combines Constraint-Induced Movement Therapy (CIMT) with Functional Electrical Stimulation (FES) for rehabilitation of the affected upper limb in children with cerebral palsy. The unaffected upper limb will be restrained using a mitt or sling to encourage active use of the affected limb during repetitive, task-oriented activities such as reaching, grasping, stacking, drawing, and object manipulation. Functional Electrical Stimulation will be applied to selected upper limb muscles including wrist extensors and finger muscles using therapeutic electrical stimulation parameters (pulse width 200-300 microseconds, frequency 35-50 Hz, and on-off cycle of 10 seconds on and 20 seconds off). The intervention will be delivered for 60 minutes per session, five sessions per week, for six weeks under physiotherapist supervision.
Constraint-Induced Movement TherapyProcedure or surgery
Constraint-Induced Movement Therapy (CIMT) will be provided to improve upper limb function in children with cerebral palsy by encouraging repetitive use of the affected extremity. The unaffected upper limb will be restrained using a mitt or sling while children perform structured, task-specific activities including grasping, reaching, releasing, drawing, feeding-related activities, stacking blocks, and play-based functional tasks. Therapy sessions will last 60 minutes each, five times per week for six weeks, with progression in task difficulty according to the child's functional abilities. No electrical stimulation will be applied in this intervention.
| Study group | Role | What they receive |
|---|---|---|
| group A CIMT Combined with FES Group | Experimental | Participants in this group will receive Constraint-Induced Movement Therapy (CIMT) combined with Functional Electrical Stimulation (FES) for the affected upper limb. Therapy will be conducted five sessions per week for six weeks, with each session lasting 60 minutes. CIMT will involve restraining the unaffected upper limb using a mitt or sling to encourage use of the affected limb during task-oriented activities such as reaching, grasping, releasing, drawing, stacking, and object manipulation. Functional Electrical Stimulation will be applied to targeted upper limb muscles including wrist extensors and finger muscles using therapeutic stimulation parameters to facilitate voluntary motor control and neuromuscular re-education. Receives: Procedure: Constraint-Induced Movement Therapy Combined with Functional Electrical Stimulation |
| group B CIMT Alone Group | Active comparator | Participants in this group will receive Constraint-Induced Movement Therapy (CIMT) alone for six weeks, five sessions per week, with each session lasting 60 minutes. The unaffected upper limb will be restrained using a mitt or sling to encourage repetitive use of the affected upper limb during functional and task-specific activities. Activities will include self-care tasks, play-based exercises, grasp and release training, drawing, stacking blocks, and object handling exercises tailored to the child's functional level. No electrical stimulation will be administered in this group. Receives: Procedure: Constraint-Induced Movement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Upper Limb Function Using Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
Upper limb function will be assessed using the Melbourne Assessment of Unilateral Upper Limb Function (MUUL), which evaluates the quality of unilateral upper extremity movement including reach, grasp, release, and object manipulation in children with cerebral palsy. Higher scores indicate better upper limb motor performance and functional ability.
Measured: 3 weeks and after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start18 May 2026
- Primary completion28 Jun 2026
- Study completion29 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montiha Azeem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Montiha Azeem, University of Lahore
- Investigators
- Muhammad Hafeezullah Tariq, MSPPT, Principal investigator, The University of Lahore, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587476
- Sponsor's protocol ID
- UOL/IREB/25/15/03/14
- Acronym
- CIMT-FES-CP
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constraint-induced Movement Therapy Combined With Functional Electrical Stimulation in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07587476
- Acronym / sponsor ID
- CIMT-FES-CP / UOL/IREB/25/15/03/14
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Constraint-Induced Movement Therapy, Functional Electrical Stimulation (FES), Upper Limb Rehabilitation, Spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Montiha AzeemUniversity, hospital or other
- Study start
- 18 May 2026 (actual)
- Primary completion
- 28 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 14 May 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 aims to compare the effectiveness of Constraint-Induced Movement Therapy (CIMT) combined with Functional Electrical Stimulation (FES) versus CIMT alone in improving upper limb function, reducing spasticity, and enhancing functional independence in children with cerebral palsy (CP). A total of 46 children aged 3 to 15 years with spastic or dyskinetic cerebral palsy will be recruited from rehabilitation centers and hospitals in Sukkur, Pakistan. Participants will be randomly assigned into two groups: Group A will receive CIMT combined with FES, while Group B will receive CIMT alone. Both groups will undergo supervised therapy sessions five times per week for six weeks. Outcomes will be assessed before and after treatment using the Modified Ashworth Scale (MAS), Melbourne Assessment of Unilateral Upper Limb Function (MUUL), and Pediatric Evaluation of Disability Inventory (PEDI). The study aims to determine whether combining FES with CIMT provides greater improvements in motor recovery and daily functional performance in children with CP.
Detailed description
Cerebral palsy (CP) is one of the most common neurological disorders in children and is frequently associated with impaired upper limb function, spasticity, reduced motor control, and limitations in performing activities of daily living. Children with spastic and dyskinetic CP often experience difficulty in reaching, grasping, releasing, and manipulating objects, which negatively affects their independence and participation in daily activities. Various rehabilitation approaches have been developed to improve upper limb performance in children with CP, among which Constraint-Induced Movement Therapy (CIMT) has shown promising results in promoting cortical reorganization and functional use of the affected extremity.
CIMT is based on restraining the less affected upper limb to encourage intensive use of the affected limb through repetitive and task-oriented activities. Although CIMT has demonstrated effectiveness in improving motor outcomes, some children still exhibit limited voluntary muscle activation and persistent spasticity that may reduce the overall effectiveness of therapy. Functional Electrical Stimulation (FES) has emerged as an adjunctive rehabilitation technique that may facilitate neuromuscular activation, improve motor learning, and enhance voluntary movement by delivering low-level electrical impulses to targeted muscles.
The present study is designed to investigate the comparative effectiveness of CIMT combined with FES versus CIMT alone in children with cerebral palsy. The study will focus on evaluating changes in spasticity, upper limb function, and functional independence following a six-week intervention program. Participants will be randomly assigned into two treatment groups. Group A will receive CIMT combined with FES, while Group B will receive CIMT alone. Both groups will receive therapy sessions five times per week under the supervision of trained physiotherapists.
Outcome measures will include the Modified Ashworth Scale (MAS) for assessment of spasticity, the Melbourne Assessment of Unilateral Upper Limb Function (MUUL) for evaluation of upper limb motor performance, and the Pediatric Evaluation of Disability Inventory (PEDI) for assessment of functional independence. Assessments will be conducted before and after the intervention period to determine treatment effectiveness.
The findings of this study may contribute to evidence-based pediatric neurorehabilitation by identifying whether the addition of FES to CIMT provides superior therapeutic benefits compared to CIMT alone. The study may also help clinicians develop more effective rehabilitation protocols aimed at improving motor recovery, independence, and quality of life in children with cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A CIMT Combined with FES Group | Experimental | Procedure: Constraint-Induced Movement Therapy Combined with Functional Electrical StimulationParticipants in this group will receive Constraint-Induced Movement Therapy (CIMT) combined with Functional Electrical Stimulation (FES) for the affected upper limb. Therapy will be conducted five sessions per week for six weeks, with each session lasting 60 minutes. CIMT will involve restraining the unaffected upper limb using a mitt or sling to encourage use of the affected limb during task-oriented activities such as reaching, grasping, releasing, drawing, stacking, and object manipulation. Functional Electrical Stimulation will be applied to targeted upper limb muscles including wrist extensors and finger muscles using therapeutic stimulation parameters to facilitate voluntary motor control and neuromuscular re-education. |
| group B CIMT Alone Group | Active comparator | Procedure: Constraint-Induced Movement TherapyParticipants in this group will receive Constraint-Induced Movement Therapy (CIMT) alone for six weeks, five sessions per week, with each session lasting 60 minutes. The unaffected upper limb will be restrained using a mitt or sling to encourage repetitive use of the affected upper limb during functional and task-specific activities. Activities will include self-care tasks, play-based exercises, grasp and release training, drawing, stacking blocks, and object handling exercises tailored to the child's functional level. No electrical stimulation will be administered in this group. |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 3 to 15 years, including both male and female population. Diagnosed with cerebral palsy (CP), confirmed by medical assessment and clinical evaluation.
- Moderate to severe impairment in upper limb function (as determined by a relevant motor function assessment scale, e.g., the Modified Ashworth Scale.
- Children with spastic and dyskinetic types of cerebral palsy. Children with cognitive ability that allows for participation in therapy, as determined by minimental status examination.
- No history of recent interventions (e.g., surgery, Botox injections) that may interfere with study participation.
Key exclusion criteria (2 listed)
- Children with contraindications to functional electrical stimulation (e.g., pacemaker, skin conditions, or open wounds in the area of electrode placement).
- Presence of other significant neurological or musculoskeletal disorders that could confound the results (e.g., traumatic brain injury, muscular dystrophy)
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 Combined with Functional Electrical StimulationThis intervention combines Constraint-Induced Movement Therapy (CIMT) with Functional Electrical Stimulation (FES) for rehabilitation of the affected upper limb in children with cerebral palsy. The unaffected upper limb will be restrained using a mitt or sling to encourage active use of the affected limb during repetitive, task-oriented activities such as reaching, grasping, stacking, drawing, and object manipulation. Functional Electrical Stimulation will be applied to selected upper limb muscles including wrist extensors and finger muscles using therapeutic electrical stimulation parameters (pulse width 200-300 microseconds, frequency 35-50 Hz, and on-off cycle of 10 seconds on and 20 seconds off). The intervention will be delivered for 60 minutes per session, five sessions per week, for six weeks under physiotherapist supervision. | Procedure or surgery | group A CIMT Combined with FES Group |
| Constraint-Induced Movement TherapyConstraint-Induced Movement Therapy (CIMT) will be provided to improve upper limb function in children with cerebral palsy by encouraging repetitive use of the affected extremity. The unaffected upper limb will be restrained using a mitt or sling while children perform structured, task-specific activities including grasping, reaching, releasing, drawing, feeding-related activities, stacking blocks, and play-based functional tasks. Therapy sessions will last 60 minutes each, five times per week for six weeks, with progression in task difficulty according to the child's functional abilities. No electrical stimulation will be applied in this intervention. | Procedure or surgery | group B CIMT Alone Group |
Primary outcome
Change in Upper Limb Function Using Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
Time frame: 3 weeks and after 6 weeks of intervention
Upper limb function will be assessed using the Melbourne Assessment of Unilateral Upper Limb Function (MUUL), which evaluates the quality of unilateral upper extremity movement including reach, grasp, release, and object manipulation in children with cerebral palsy. Higher scores indicate better upper limb motor performance and functional ability.
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 6 Jul 2026.
Related trials for Cerebral Palsy (CP)
Not yet recruiting
Ayres Sensory Integration Intervention for Children With Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
Not yet recruitingObservational study
Turkish Translation, Cross-Cultural Adaptation, Validity, and Reliability of the ABILHAND-Kids Young CP Scale
Cerebral Palsy
Recruiting
Repetitive Transcranial Magnetic Stimulation on Motor Function and Meta-Plasticity in Cerebral Palsy: TMS-EEG Study
Cerebral Palsy, Typically Developing Children
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intravenous Infusion for CP
Cerebral Palsy
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.
Muhammad Hafeezullah Tariq, MSPPT principal investigator
The University of Lahore, Lahore
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 Combined with Functional Electrical Stimulation and Constraint-Induced Movement Therapy in people with Cerebral Palsy (CP), run by Montiha Azeem 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 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: finished, as of the sponsor's last update on 6 Jul 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?
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?
Change in Upper Limb Function Using Melbourne Assessment of Unilateral Upper Limb Function (MUUL) (time frame: 3 weeks and after 6 weeks of intervention). 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 6 Jul 2026.