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

NCT03580174 | Completed

• 1 other identifier: 57/30
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Physical therapy; ICF; Botulinum toxin; Activity; Function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Manual Muscle Test

  10 min

• Gait Analysis

  10 min

• Gillette Functional Gait Assessment

  5 min

• Pediatric Balance Scale

  5 min

• Gross Motor Function Measurement

  15 min

Study Arms (2)

Goal directed physiotherapy group

ACTIVE COMPARATOR

Ten children with CP will receive structural, comprehensive activity based, goal directed physiotherapy

Other: Goal directed physiotherapy group

Routine physiotherapy group

ACTIVE COMPARATOR

Ten children with CP will receive conventional, traditional physiotherapy

Other: Routine physiotherapy group

Interventions

Goal directed physiotherapy group OTHER

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.

Goal directed physiotherapy group

Routine physiotherapy group OTHER

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.

Routine physiotherapy group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Sıhhıye, 06100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 35224682 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Motor Activity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Officials

• Mintaze GÜNEL, Prof.

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assisstant, MSc, PT

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: July 9, 2018
• Study Start: February 1, 2019
• Primary Completion: May 5, 2019
• Study Completion: June 18, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

TU (1)