The Effects of Physiotherapy and Rehabilitation Programs Following Botulinum Toxin on Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

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.
    

Intervention name(s): Goal directed physiotherapy group; Routine physiotherapy group
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physical therapy; ICF; Botulinum toxin; Activity; Function