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

NCT04064788 | Completed

• 1 other identifier: AIBU-FTR-ST-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spastic Hemiplegic Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• Children's Hand-Use Experience Questionnaire (CHEQ)

  Assessing children's experience of using the affected hand in activities of daily living where usually two hands are needed. There are 29 items at questionnaire. When respondents answered the questionnaire, they were first asked whether the activity included in the questionnaire was conducted independently. If the activities can be done independently, it is questioned whether one or two hands are used during the activities. If two hands are used, answers and scores to the following 3 sub-questions are sought: hand use, time use in comparison to peers, experience of feeling bothered while doing the activity. A higher score indicates a better level of independence.

  Change from Baseline at 10 days and at 5 weeks

• Jebsen-Taylor Hand Function Test

  This is an objective test to evaluate hand function for a person's activities of daily living. Test consist of 7 subtests includes writing, card turning, manipulate small common objects, simulated feeding, stacking checkers, moving large light objects and moving large heavy objects. We will use 6 subtests except writing in our study.

  Change from Baseline at 10 days and at 5 weeks

Secondary Outcomes (7)

• Gross Motor Classification System (GMFCS)

  At Baseline

• Manual Ability Classification System (MACS)

  At Baseline

• Pediatric Balance Scale (PBS)

  At Baseline

• Modified Tardieu Scale (MTS)

  Change from Baseline at 10 days and at 5 weeks

• ABILHAND-Kids Questionnaire

  Change from Baseline at 10 days and at 5 weeks

Study Arms (3)

Consecutive mCIMT group

EXPERIMENTAL

6 hours / day, 10 consecutive days, 60 hours mKZHT + 2 days 45 minutes / day traditional physiotherapy

Other: Consecutive Modified Constraint-Induced Movement Therapy

Intermittent mCIMT group

EXPERIMENTAL

6 hours / day 2 days a week 5 weeks, a total of 60 hours mKZHT + 2 days 45 min / day traditional physiotherapy

Other: Intermittent Modified Constraint-Induced Movement Therapy

Traditional physiotherapy control group

ACTIVE COMPARATOR

45 min / day, 2 days a week traditional physiotherapy

Other: Traditional physiotherapy

Interventions

Consecutive Modified Constraint-Induced Movement Therapy OTHER

Consecutive mCIMT group received 6 hours per day mCIMT sessions for consecutive 10 days. Accompanied by a physiotherapist in 1 hour of the 6-hour restriction period, the family was guided within the remaining period and the activities were adapted to daily life.

Consecutive mCIMT group

Traditional physiotherapy OTHER

Traditional physiotherapy within a specific program

Traditional physiotherapy control group

Intermittent Modified Constraint-Induced Movement Therapy OTHER

Intermittent mCIMT group received mCIMT session 6 hours per day for 10 days, spread over 5 weeks (two days per week). Accompanied by a physiotherapist in 1 hour of the 6-hour restriction period, the family was guided within the remaining period and the activities were adapted to daily life.

Intermittent mCIMT group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• confirmed diagnosis of hemiplegic CP
• years of age
• MACS level I, II or III
• GMFCS level I
• To have sufficient communication skills
• To be able to extend the wrist at least 20 degrees
• Lack of severe spasticity to prevent grasping and dropping objects
• Surgery or application of Botulinum toxin within the last 6 months
• The family's acceptance of the child's participation in the study
• The child volunteers to participate in the study

You may not qualify if:

• Visual and hearing impairment
• Family refuses to participate in the study
• There is a walking and balance problem that may cause a fall risk during the use of a sling
• Behavioral problems at the level to reject the practices to be performed within the study

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University

Bolu, 14280, Turkey (Türkiye)

Location

Related Publications (4)

• Taub E, Ramey SL, DeLuca S, Echols K. Efficacy of constraint-induced movement therapy for children with cerebral palsy with asymmetric motor impairment. Pediatrics. 2004 Feb;113(2):305-12. doi: 10.1542/peds.113.2.305.

  PMID: 14754942 BACKGROUND

• Brady K, Garcia T. Constraint-induced movement therapy (CIMT): pediatric applications. Dev Disabil Res Rev. 2009;15(2):102-11. doi: 10.1002/ddrr.59.

  PMID: 19489088 BACKGROUND

• Hoare BJ, Wasiak J, Imms C, Carey L. Constraint-induced movement therapy in the treatment of the upper limb in children with hemiplegic cerebral palsy. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004149. doi: 10.1002/14651858.CD004149.pub2.

  PMID: 17443542 BACKGROUND

• Stearns GE, Burtner P, Keenan KM, Qualls C, Phillips J. Effects of constraint-induced movement therapy on hand skills and muscle recruitment of children with spastic hemiplegic cerebral palsy. NeuroRehabilitation. 2009;24(2):95-108. doi: 10.3233/NRE-2009-0459.

  PMID: 19339749 BACKGROUND

Study Officials

• Tamer Çankaya

  Abant Izzet Baysal University

  STUDY DIRECTOR

• Sezen Tezcan

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 22, 2019
• Study Start: September 1, 2019
• Primary Completion: September 15, 2020
• Study Completion: January 8, 2021
• Last Updated: February 15, 2021

Record last verified: 2021-02

Locations

TU (1)