Clinical trial NCT03580174: The Effects of Physiotherapy and Rehabilitation Programs Following Botulinum Toxin on Children With Cerebral Palsy
Official title: Investigation of the Effects of Physiotherapy and Rehabilitation Programs Following Botulinum Toxin Injection on Body Functions, Activity and Participation in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Physical therapy
ICF
Botulinum toxin
Activity
Function
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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

Primary outcomes:
measure: Modified Physician Rating Scale
timeFrame: 10 minutes
Secondary outcomes:
measure: Manual Muscle Test
timeFrame: 10 min
measure: Gait Analysis
timeFrame: 10 min
measure: Gillette Functional Gait Assessment
timeFrame: 5 min
measure: Pediatric Balance Scale
timeFrame: 5 min
measure: Gross Motor Function Measurement
timeFrame: 15 min
measure: Parent-reported questionnaire
timeFrame: 2 min
measure: Modified Ashworth Scale
timeFrame: 5 min
measure: Selective Control Assessment of Lower Extremity
timeFrame: 3 min
measure: Trunk Control Measurement Scale
timeFrame: 15 min
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Sıhhıye
Study officials:
affiliation: Hacettepe University
name: Mintaze GÜNEL, Prof.
role: STUDY_DIRECTOR
References:
citation: Biyik KS, Gunel MK, Akyuz EU. How does treadmill training contribute to botulinum toxin application plus routine physical therapy in ambulatory children with spastic bilateral cerebral palsy? A randomized controlled trial. Ir J Med Sci. 2023 Feb;192(1):209-217. doi: 10.1007/s11845-022-02960-9. Epub 2022 Feb 27.