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).
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.
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 group | Role | What they receive |
|---|---|---|
| Goal directed physiotherapy group | Active comparator | Ten children with CP will receive structural, comprehensive activity based, goal directed physiotherapy Receives: Other: Goal directed physiotherapy group |
| Routine physiotherapy group | Active comparator | Ten 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.
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)
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
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
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
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
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
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
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
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
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.
- First posted9 Jul 2018
- Study start1 Feb 2019
- Primary completion5 May 2019
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Seyhan, Hacettepe University
- Investigators
- Mintaze GÜNEL, Prof., Study director, Hacettepe University
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03580174
- Acronym / sponsor ID
- 57/30
- Conditions
- Cerebral Palsy
- Keywords
- Physical therapy, ICF, Botulinum toxin, Activity, Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 9 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Goal directed physiotherapy group | Active comparator | Other: Goal directed physiotherapy groupTen children with CP will receive structural, comprehensive activity based, goal directed physiotherapy |
| Routine physiotherapy group | Active comparator | Other: Routine physiotherapy groupTen children with CP will receive conventional, traditional physiotherapy |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- who had lower extremity surgery in last six months
- who have repeated BT during the study
- do not want to continue the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal directed physiotherapy groupTen 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. | Other | Goal directed physiotherapy group |
| Routine physiotherapy groupTen 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. | Other | Routine physiotherapy group |
Primary outcome
Modified Physician Rating Scale
Time frame: 10 minutes
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.
9 secondary outcomes
Manual Muscle Test
Time frame: 10 min
Gait Analysis
Time frame: 10 min
Gillette Functional Gait Assessment
Time frame: 5 min
Pediatric Balance Scale
Time frame: 5 min
Gross Motor Function Measurement
Time frame: 15 min
Parent-reported questionnaire
Time frame: 2 min
Modified Ashworth Scale
Time frame: 5 min
Selective Control Assessment of Lower Extremity
Time frame: 3 min
Trunk Control Measurement Scale
Time frame: 15 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Derived from this study: PubMed 35224682Biyik 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.
- Individual participant dataSharing planned: Undecided
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mintaze GÜNEL, Prof. study director
Hacettepe University
1 site in 1 country: see every site and its status.
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.