- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07587476
Constraint-induced Movement Therapy Combined With Functional Electrical Stimulation in Children With Cerebral Palsy (CIMT-FES-CP)
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Hira medical center Sukkur
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
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.
Exclusion Criteria:
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: group A CIMT Combined with FES Group
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.
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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.
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Aktiv komparator: group B CIMT Alone Group
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.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Upper Limb Function Using Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
Tidsram: 3 weeks and after 6 weeks of intervention
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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.
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3 weeks and after 6 weeks of intervention
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Muhammad Hafeezullah Tariq, MSPPT, The University of Lahore, Lahore
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neurologiska manifestationer
- Muskuloskeletala sjukdomar
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Muskelsjukdomar
- Muskelhypertoni
- Neuromuskulära manifestationer
- Hjärnskada, kronisk
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Muskelspasticitet
- Cerebral pares
- Terapeutik
- Fysioterapimetoder
- Träningsterapi
- Rehabilitering
- Constraint Induced Movement Therapy
Andra studie-ID-nummer
- UOL/IREB/25/15/03/14
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