Investigation of the Effect of Constraint Induced Movement Therapy Applied to the Lower Extremity on Lower Extremity Functions in Individuals With Unilateral Cerebral Palsy

NCT06753812 | Enrolling By Invitation

• 1 other identifier: AIBU-FTR-ANN-02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Lower extremity constraint induced movement therapy has been applied to individuals with multiple sclerosis, stroke, subacute and chronic hemiparesis in recent years and positive results have been reported. However, there is no study in the literature regarding the application of this treatment method to the pediatric population. In order to address this gap in the literature, we planned to conduct this study to examine the possible effects of lower extremity constraint induced movement therapy on lower extremity functions, balance and gait parameters in individuals with cerebral palsy.

Conditions

Cerebral Palsy Spastic Hemiplegic

Keywords

cerebral palsy; Surface Electromiyography; lower extremity

Outcome Measures

Primary Outcomes (1)

• Surface EMG

  Electromyography is a method used to record and analyze myoelectric signals; it provides information about the transfer of the signals to the neuromuscular junction, the electrical activation of muscle cells in the motor unit, muscular contraction and relaxation strategies and activation time. sEMG measurements made on the individual's skin using superficial electrodes are frequently preferred for research purposes because they are non-invasive and painless. In sEMG application, electrodes are usually placed in the center of the muscle body for large superficial muscles and on the target muscle for small muscles. The maximal voluntary isometric contraction (MVIC) value of the muscles will be calculated and recorded with electromyographic evaluation in the individuals participating in the study. The results of the pre-evaluation and post-evaluation will be compared. The muscle groups to be evaluated within the scope of our study are M. Rectus Femoris and M. Gastrocnemius.

  6 weeks

Secondary Outcomes (13)

• Modified Tardieu Scale

  6 weeks

• Gross Motor Function Measure (GMFM-88 Dimensions D and E)

  6 weeks

• Selective Control Assessment of the Lower Extremity- SCALE

  6 weeks

• Observational Gait Analysis-OGS

  6 weeks

• Gross Motor Function Classification System

  6 weeks

Study Arms (2)

Constraint induced movement therapy group

ACTIVE COMPARATOR

Children in this group will receive constraint induced movement therapy in addition to conventional physical therapy twice a week.

Other: constraint induced movement therapy

Control group

OTHER

Children in this group will continue to receive their treatment twice a week at the special education and rehabilitation center where they are currently registered and attending.

Other: Control (Standard treatment)

Interventions

constraint induced movement therapy OTHER

Children in this group will receive constraint induced movement therapy for 10 sessions over 2 weeks, each session lasting 90 minutes, in addition to the treatment they receive 2 days a week at the special education and rehabilitation centers they attend.

Constraint induced movement therapy group

Control (Standard treatment) OTHER

Children in this group will continue to receive their treatment at the special education and rehabilitation center they attend, two days a week for 40 minutes.

Control group

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Having been diagnosed with Cerebral Palsy by a Child Neurologist.
• Having been classified as Unilateral Cerebral Palsy according to SCPE.
• Being between the ages of 5-15,
• Being at levels I-II according to the Gross Motor Function Classification System
• Being at levels I-II according to the Communication Function Classification System
• Being able to stand up from sitting independently, even with the help of the upper extremity
• Being able to walk at least 10 m with or without an assistive device

You may not qualify if:

• Children who have had lower extremity orthopedic surgery within the last six months
• Children who have had lower extremity Botox injections within the last six months
• Those with rigid contractures involving lower extremity joints,
• Children with levels III-IV according to the Communication Functions Classification System
• Families and children who do not accept full participation in treatment

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant İzzet Baysal University Faculty of Health Sciences

Bolu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 2 groups with a conventional therapy control group

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 31, 2024
• Study Start: January 15, 2025
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)