The Effects of Physiotherapy and Rehabilitation Programs Following Botulinum Toxin on Children With Cerebral Palsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-06-18

Brief Summary

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The purpose of this study was to investigate the effects of Physiotherapy and rehabilitation program on body functions and structures, activity and participation levels, personal and environmental factors following Multilevel Botulinum toxin (BT) injections on ambulatory children with Cerebral Palsy (CP). Two physiotherapy and rehabilitation methods which are structural goal directed activity based physiotherapy (intervention group; 10 children with ambulatory Cerebral Palsy) and unstructured routine physiotherapy (control group; 10 children with ambulatory Cerebral Palsy) will be compared.

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Detailed Description

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The purpose of this study was to investigate the effects of Physiotherapy and rehabilitation program following Multilevel Botulinum toxin (BT) injections on ambulatory children with Cerebral Palsy (CP). Children who are 3-12 years, have Diplegic CP, able to walk with/without support (between GMFCS level I-III), have multilevel botulinum toxin injections to lower extremity muscles, able to communicate, whose parents agree to participate will include in this study. Children who had lower extremity surgery in last six months, who have repeated BT during the study, do not want to continue the study will exclude the current study. It is planned to receive at least 20 children with CP. Children will be divided into two groups: ten children in routine physiotherapy (RPT) group (traditional methods, stretch, massage etc.) and ten children in goal directed activity based physical therapy (GDPT) group (structural concept).

Routine Physiotherapy (RPT) group: Ten children with CP will RPT applications will consist of unstructured stretching exercises, massage, passive range of motions, muscle strengthening, orthotics etc.) .

Goal Directed Activity Based Physical Therapy (GDPT) group: Ten children with CP will receive structural, comprehensive activity based, goal directed therapy protocol one hour in a session, 2 times in a week during 8 weeks. GDPT will be a structural protocol and consists of daily life activities as sit to stand and reach, treadmill exercises, balance exercises with bosu-ball, orthotics, home program, following with exercise-diary.

Hypothesis 1: GDPT program applied after multilevel BT injection in children with CP affects the body structure and functions.

Hypothesis 2: GDPT program applied after multilevel BT injection in children with CP affects the activity.

Hypothesis 3: GDPT program applied after multilevel BT injection in children with CP affects the participation.

Hypothesis 4: GDPT after BT injection in children with CP affects the activity of the child more than RPT.

The first evaluation will be made in the first week after BT injection. After 8 weeks therapy program is applied, the second evaluation will be made.

The assessments to be implemented under the International Classification of Functioning (ICF) framework are as follows:

Body structure and functions

* Muscle tone (Modified Ashworth Scale-MAS)
* Muscle Strength (with Manual Muscle Tester Device)
* Lower Extremity Selective Motor Control (Selective Control Assessment of Lower Extremity- SCALE)
* Spatiotemporal characteristics of gait (Gait trainer)

Activity and participation:

* Balance (Pediatric Balance Scale- PBS)

. Trunk Control (Trunk Control Measurement Scale -TCMS)
* Pediatric Evaluation of Disability Inventory (PEDI)
* Gait Analysis (Modified Physician Rating Scale (MPRS); Gillette Functional Gait Assessment)
* Motor Function (Gross Motor Function Measurement -GMFM)

Personal and Environmental Factors:

Level of anxiety and satisfaction of parents and children will be rated between 11-point scale on self reported questionnaire.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

There will be two groups as Routine Physiotherapy group and Goal Directed Activity Based Physical Therapy (GDPT) group.

* Routine Physiotherapy (RPT) group: Ten children with CP will RPT applications will consist of unstructured stretching exercises, massage, passive range of motions, muscle strengthening, orthotics etc.) .
* Goal Directed Activity Based Physical Therapy (GDPT) group: Ten children with CP will receive structural, comprehensive activity based, goal directed therapy protocol one hour in a session, 2 times in a week during 8 weeks. GDPT will be a structural protocol and consists of daily life activities as sit to stand and reach, treadmill exercises, balance exercises with bosu-ball, orthotics, home program, following with exercise-diary.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Goal directed physiotherapy group

Ten children with CP will receive structural, comprehensive activity based, goal directed physiotherapy

Group Type ACTIVE_COMPARATOR

Goal directed physiotherapy group

Intervention Type OTHER

Ten children with CP will receive structural, comprehensive activity based, goal directed therapy protocol one hour in a session, 2 times in a week during 8 weeks. GDPT will be a structural protocol and consists of daily life activities as sit to stand and reach, treadmill exercises, balance exercises with bosu-ball, orthotics, home program, following with exercise-diary.

Routine physiotherapy group

Ten children with CP will receive conventional, traditional physiotherapy

Group Type ACTIVE_COMPARATOR

Routine physiotherapy group

Intervention Type OTHER

Ten children with CP will RPT applications will consist of unstructured stretching exercises, massage, passive range of motions, muscle strengthening, orthotics etc.) one hour in a session, 2 times in a week during 8 weeks.

Interventions

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Goal directed physiotherapy group

Ten children with CP will receive structural, comprehensive activity based, goal directed therapy protocol one hour in a session, 2 times in a week during 8 weeks. GDPT will be a structural protocol and consists of daily life activities as sit to stand and reach, treadmill exercises, balance exercises with bosu-ball, orthotics, home program, following with exercise-diary.

Intervention Type OTHER

Routine physiotherapy group

Ten children with CP will RPT applications will consist of unstructured stretching exercises, massage, passive range of motions, muscle strengthening, orthotics etc.) one hour in a session, 2 times in a week during 8 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 3-12 years,
* have Diplegic CP
* able to walk with/without support (between GMFCS level I-III)
* have multilevel botulinum toxin injections to lower extremity muscles
* able to communicate
* whose parents agree to participate