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Cerebral PalsyNCT03580174

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

A study testing Goal directed physiotherapy group and Routine physiotherapy group in people with Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 3 to 12 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Goal directed physiotherapy group and Routine physiotherapy group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2019to 18 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hacettepe University

    Ankara, Sıhhıye, 06100

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Conditions
Cerebral Palsy
Being tested
Goal directed physiotherapy group, Routine physiotherapy group
Keywords
Physical therapy, ICF, Botulinum toxin, Activity, Function
Medical subject headings
Cerebral Palsy, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Goal directed physiotherapy groupOther

    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.

  • Routine physiotherapy groupOther

    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.

Study groups in NCT03580174
Study groupRoleWhat they receive
Goal directed physiotherapy groupActive comparatorTen children with CP will receive structural, comprehensive activity based, goal directed physiotherapy
Receives: Other: Goal directed physiotherapy group
Routine physiotherapy groupActive comparatorTen children with CP will receive conventional, traditional physiotherapy
Receives: Other: Routine physiotherapy group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 10 minutes

Secondary outcomes (9)
  1. 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.

    Measured: 10 min

  2. 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.

    Measured: 10 min

  3. 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.

    Measured: 5 min

  4. 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.

    Measured: 5 min

  5. 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.

    Measured: 15 min

  6. 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.

    Measured: 2 min

  7. 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).

    Measured: 5 min

  8. 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.

    Measured: 3 min

  9. 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.

    Measured: 15 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2018
  2. Study start1 Feb 2019
  3. Primary completion5 May 2019
  4. Study completion18 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03580174
Sponsor's protocol ID
57/30
Status last verified
Jan 2020
First submitted
31 May 2018
Last updated
9 Jan 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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. 2023 Feb;192(1):209-217. doi: 10.1007/s11845-022-02960-9. Epub 2022 Feb 27.

    PubMed 35224682

Questions about this trial

What is this clinical trial studying?

A study testing Goal directed physiotherapy group and Routine physiotherapy group in people with Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Physician Rating Scale (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03580174, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.

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