Investigation of the Effects of Physiotherapy and Rehabilitation Programs Following Botulinum Toxin Injection on Body Functions, Activity and Participation in Children With Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hacettepe University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Modified Physician Rating Scale
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Goal directed physiotherapy group
Ten children with CP will receive structural, comprehensive activity based, goal directed physiotherapy
Intervention: Goal directed physiotherapy group (Other)
Routine physiotherapy group
Ten children with CP will receive conventional, traditional physiotherapy
Intervention: Routine physiotherapy group (Other)
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)
Investigators
Kübra Seyhan
Research Assisstant, MSc, PT
Hacettepe University