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Clinical Trials/NCT03580174
NCT03580174
Completed
N/A

Investigation of the Effects of Physiotherapy and Rehabilitation Programs Following Botulinum Toxin Injection on Body Functions, Activity and Participation in Children With Cerebral Palsy

Hacettepe University1 site in 1 country24 target enrollmentFebruary 1, 2019
ConditionsCerebral Palsy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Hacettepe University
Enrollment
24
Locations
1
Primary Endpoint
Modified Physician Rating Scale
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
June 18, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kübra Seyhan

Research Assisstant, MSc, PT

Hacettepe University

Eligibility Criteria

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

Exclusion Criteria

  • who had lower extremity surgery in last six months
  • who have repeated BT during the study
  • do not want to continue the study

Outcomes

Primary Outcomes

Modified Physician Rating Scale

Time Frame: 10 minutes

The Modified Physicians' Rating Scale (MPRS) is an observational tool that has been used to evaluate gait and assess the outcome of botulinum toxin injection in children with cerebral palsy. This is a scale adapted from the Physicians rating scale which was created to examine the gait of children with CP in the sagittal plane after botulinum toxin A for equinus gait. It is a scale with 8 sections where you score both the left and right lower extremity from video record of child's gait. The score ranged 0 to 22 point. A perfect score would be a 22 on each limb. MPRS should be observed from front and sides of children with CP.

Secondary Outcomes

  • Manual Muscle Test(10 min)
  • Pediatric Balance Scale(5 min)
  • Trunk Control Measurement Scale(15 min)
  • Parent-reported questionnaire(2 min)
  • Modified Ashworth Scale(5 min)
  • Gait Analysis(10 min)
  • Gillette Functional Gait Assessment(5 min)
  • Gross Motor Function Measurement(15 min)
  • Selective Control Assessment of Lower Extremity(3 min)

Study Sites (1)

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