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

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Goal directed physiotherapy group; Other: Routine physiotherapy group

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sıhhıye
    • Ankara, Sıhhıye, Turkey, 06100
      • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Goal directed physiotherapy group; Ten children with CP will receive structural, comprehensive activity based, goal directed physiotherapy	Other: 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.
ACTIVE_COMPARATOR: Routine physiotherapy group; Ten children with CP will receive conventional, traditional physiotherapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Physician Rating Scale	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.	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Manual Muscle Test	Manual muscle tester (hand held dynamometer) will use for quantifying objectively strength of lower extremity muscles. Dynamometry provides an objective measure of isometric strength against examiner resistance by quantifying the mechanical force or torque. Hand-held dynamometry (HHD) was used to measure the force (in Newtons) generated during an isometric contraction. This device records force for intervals of 0.1 N up to a maximum 99.9 N, thereafter in whole Newtons. These were recorded in order, as trials 1 to 3.	10 min
Gait Analysis	Spatiotemporal gait deviation of children will be evaluated with Biodex Gait Trainer 2 like as a treadmill gait analysis. The device will give us about "Average Walking Speed, Average Step Cycle, Average Step Length, Coefficient of Variance, Right/left time distribution, Ambulation Index. The composite score's goal is 100. The higher point is the better.	10 min
Gillette Functional Gait Assessment	Level of locomotion will assess with Gillette Functional Gait Assessment that was a 10-level, parent-report walking scale and encompassing a range of walking abilities from nonambulatory to ambulatory in all community settings and terrains was developed at Gillette Children's Specialty Healthcare (GCSH) as part of the Gillette Functional Assessment Questionnaire (FAQ). Gait was ranged between 1 to 10 level. The high point determined better locomotion level.	5 min
Pediatric Balance Scale	Balance will evaluated with Pediatric Balance Scale (PBS). It has 14 item. Maximum point 56 points with 56 points being a perfect score.	5 min
Gross Motor Function Measurement	Motor Functions of children will be evaluated with Gross Motor Function Measurement (GMFM). It is a clinical tool designed to evaluate change in gross motor function in children with cerebral palsy.There is 88 items under 5 subdimensions (lying and rolling, sitting, crawling and kneeling, standing, walking-running-jumping) with a 4-point scoring system for each item. The percentage of sub-dimensions and total scores calculated separately. The higher percentage score (ranged between 0-100 point) was the better gross motor function.	15 min
Parent-reported questionnaire	We prepare a questionnaire for asking the level of anxiety and satisfaction of parents. The 11-point numeric scale ranges from '0' representing parent feeling negatively to '10' representing parent feeling positively.	2 min
Modified Ashworth Scale	Tone of lower extremity muscles will be assessed with Modified Ashworth Scale. The Modified Ashworth scale s (MAS) is the most frequently cited of the available clinical rating scales to measure tonal abnormality. It is already being used to evaluate the effects of drug treatments for spasticity. The spasticity of each muscle ranged between 0 to 5. (0:No increase in muscle tone,1:Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is(are) moved in flexion or extension, 2: Slight increase in muscle tone, manifested by a catch followed by minimal resistance through the remainder of the range of motion but the affected part(s) is(are) easily moved, 3;More marked increase in muscle tone through most of the range of movement, but affected part(s) easily moved, 4:Considerable increase in muscle tone, passive movement difficult, 5:Affected part(s) is(are) rigid in flexion or extension).	5 min
Selective Control Assessment of Lower Extremity	Lower Extremity Selective Motor Control will be evaluated with Selective Control Assessment of Lower Extremity (SCALE). The SCALE tool was designed for clinical administration and scoring by health car e professionals, to be used without specialized equipment. The tool includes 'Directions for Administration,' 'Instructions for Grading,' and a 'Score Sheet.' Hip , knee, ankle, sub-talar, and toe joints are assessed bilaterally. Selective movement control is graded at each joint as 'Normal' (2 points), 'Impaired' (1 point), or 'Unable' (0 points). The higher point is the better selectivity of movement.	3 min
Trunk Control Measurement Scale	Trunk Control will be assessed with Trunk Control Measurement Scale (TCMS) in children with CP. The TCMS divided three sub-dimensions like as static sitting balance, selective movement control and dynamic reaching. The maximum value for the total TCMS is 58 (20 points for the category static sitting balance, 28 points for selective movement control and 10 for dynamic reaching). A higher TCMS scores indicates a better performance in trunk control.	15 min

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Director: Mintaze GÜNEL, Prof., Hacettepe University

Publications and helpful links

General Publications

• 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. 2022 Feb 27. doi: 10.1007/s11845-022-02960-9. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ACTUAL): May 5, 2019
• Study Completion (ACTUAL): June 18, 2019

Study Registration Dates

• First Submitted: May 31, 2018
• First Submitted That Met QC Criteria: June 25, 2018
• First Posted (ACTUAL): July 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: ICF; Physical therapy; Function; Activity; Botulinum toxin
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 57/30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No