NCT04064788

Modified Constraint-Induced Movement Therapy in Children With Hemiparetic Cerebral Palsy

Completed NA Last updated 15 February 2021

What this trial tests

NA trial testing Consecutive Modified Constraint-Induced Movement Therapy in Spastic Hemiplegic Cerebral Palsy in 33 participants. Completed in 8 January 2021.

Timeline

1 September 2019

Primary endpoint
15 September 2020

8 January 2021

Quick facts

Lead sponsor	Abant Izzet Baysal University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	33
Start date	1 September 2019
Primary completion	15 September 2020
Estimated completion	8 January 2021
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Consecutive Modified Constraint-Induced Movement Therapy
• Traditional physiotherapy
• Intermittent Modified Constraint-Induced Movement Therapy

Conditions studied

• Spastic Hemiplegic Cerebral Palsy — all drugs for Spastic Hemiplegic Cerebral Palsy →

Sponsor

Abant Izzet Baysal University

Who can join

Adults 5 to 18, any sex, with Spastic Hemiplegic Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cerebral palsy (CP) is defined as a non-progressive lesion of the developing foetal or infant brain and causes variety of motor, sensory and cognitive impairments. Hemiplegic CP is the most common type of CP in term infants, involving one half of the body. In these individuals, muscle tone is reduced, and there is an inability to perform quality upper extremity movements due to increased muscle tone, increased reflexes, weakness in antagonist muscles. Due to spasticity upper extremity is present in shoulder adduction and internal rotation, elbow flexion and pronation, wrist and fingers flexed and thumb in palm position. Spontaneous movements of the upper extremity are decreased and abnormal. These individuals have a reduced upper extremity function ranging from mild incompetence to almost no use of the hand.

Constraint-Induced Movement Therapy (CIMT) is designed to improve the function of the most affected limb by restricting the use of the less affected limb in individuals with unilateral upper extremity involvement and implementing an intensive motor learning-based training program. In pediatric subjects, modified CIMT (mCIMT), which is called a 'child-friendly technique', has been applied, which shows some differences from the form of CIMT in adults. In mCIMT, the restriction time was reduced, activities with the child were performed within a play frame, in the environment in which the child was accustomed, and restriction methods such as gloves, splint, sling were used. In the literature CIMT has been used mainly in children with hemiplegic CP in the pediatric population. However, there are many studies in the literature evaluating the efficacy of mCIMT in individuals with hemiplegic CP and showing beneficial effects on upper extremity speed and skills, and the duration of application restriction varies considerably.

The aim of the investigator's study was to determine the effect of consecutive or intermittent implementation of mCIMT on upper extremity function in children with hemiplegic CP. Thus, it will be determined whether the modification of the duration of administration in the pediatric population varies in treatment results.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.