Focal Hand DystoniaNCT03664375
Impact Of Physiotherapy And Botox In Improving Functional Outcomes Among Post Stroke Focal Dystonia Patients
A study testing Botulinum toxin type A and Task Specific Training in people with Focal Hand Dystonia, run by Isra University.
Trial summary
This study was conducted to assess the combine role of Physiotherapy by providing task specific trainings and Botulinum Toxin Type A in improving the functional outcomes of upper limb in post stroke patients with focal hand dystonia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Focal Hand Dystonia
- What is being tested?
- Botulinum toxin type A and Task Specific Training
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Dec 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having first episode of unilateral stroke
- At least 6 months of post stroke duration presenting with post stroke focal dystonia of the upper limb.
- No previous exposure of the affected hand of Botox.
- Reduced upper limb functions
- Both genders will be included equally.
Who cannot join
- Significant speech or cognitive impairment which impedes the ability to perform the assessment.
- Other significant upper limb impairment e.g. fracture or frozen shoulder within 6 months.
- Severe arthritis, amputation, evidence of fixed contracture, pregnancy or lactating womens.
- Other diagnosis likely to interfere with rehabilitation or outcome assessments, e.g. blind, malignancy,
- Other conditions which may contribute to upper limb spasticity, e.g. multiple sclerosis, cerebral palsy.
- Use of botulinum toxin to the upper limb in the previous 4 months.
- Contraindications to intramuscular injection.
- Contraindications /allergy to botulinum toxin type A, which include bleeding disorders, myasthenia gravis and concurrent use of aminoglycosides.
About this study
Official title: Impact Of Physiotherapy And Botulinum Toxin Type-A In Improving Functional Outcomes In Upper Limb Focal Dystonia Among Post Stroke Patients
This study was conducted to assess the combine role of Physiotherapy by providing task specific trainings and Botulinum Toxin Type A in improving the functional outcomes of upper limb in post stroke patients with focal hand dystonia.
Read the detailed description
Post-stroke hemiparesis, with dystonia, is a major cause of disability. Dystonia can hinder the functional activities making patient dependent on others for performance of daily living activities. Dystonia not only limits the physical activity of the patient but also affects their quality of life significantly. Various treatment protocols have been used in the literature for treatment of focal hand dystonia in the past including deep brain stimulation, kinesio taping, sensory oriented training, splinting, extracorporeal shock wave therapy and botox. Out of these Botox has gained much importance but it results only in improving the passive range of motion and has no consensus in improving the active range of motion and functional independence of the patient. The current study was planned to determine the effects of botulinum toxin type A combined with task-specific therapy, for post-stroke focal dystonia of upper limb.
- Conditions
- Focal Hand Dystonia
- Being tested
- Botulinum toxin type A, Task Specific Training
- Keywords
- Dystonia Task-specific training Botulinum toxin type A
- Medical subject headings
- Dystonia, Focal, Task-Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All patients in the experimental group received a BoNT-A injection. The injected total dose for individual patient in the experimental group was 100 units which is equivalent to approximately 300-500 Units of Dysport (the other type of BoNT-A available). The Botox was injected by the neurophysician intramuscularly using insulin U100 syringe and determination of muscles for injection was assessed clinically.
Task Specific TrainingOther
Task specific training is the repetition of a specific task until expertise is reached. More challenging tasks are added as a means of progression
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group received botulinum toxin type A. After one week of Botox administration, a specially made task specific training program was started for these patients. It was provided for a duration of one hour and for three times per week for a total of 12 weeks by a trained physiotherapist. Receives: Other: Botulinum toxin type A; Other: Task Specific Training |
| Control Group | Placebo comparator | The control group received only task specific training program with the same protocol as for the experimental group; for a duration of one hour and for three times per week up to a total of 12 weeks by a trained physiotherapist Receives: Other: Task Specific Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test (ARAT):
It assessed specific changes in limb function by 19 items grouped in four subscales. The total score ranged from 0 to 57. The lower score indicated no movement and upper score indicated normal performance of the patient.
Measured: 12 weeks
MOTOR ASSESSMENT SCALE (MAS)
It was a performance-based scale, based on a task-oriented approach to evaluate and assesses performance of functional tasks rather than isolated patterns of movement. All items were assessed using a 7-point scale from 0 - 6. A score of 6 indicated optimal motor behavior.
Measured: 12 weeks
WOLF MOTOR FUNCTION TEST (WMFT)
It quantified motor ability through timed functional tasks. It used a 6-point ordinal scale with "0" = "does not attempt with the involved arm" to "5" = movement appears to be normal."
Measured: 12 weeks
FUGL- MEYER ASSESSMENT TEST
It was a performance-based impairment index to measure motor functioning. The total score possible was from 0 - 66, with higher function showing the improved level of independence
Measured: 12 weeks
Secondary outcomes (2)
Severity Of Dystonia
The Arm Dystonia Disability Scale: The severity of dystonia was assessed using 0 (None) to 3 (Marked Difficulty in performing activity
Measured: 12 weeks
Stroke Specific Quality Of Life
The stroke specific Quality Of Life was administered to patients which rated their Quality of life
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study startNov 2015
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Hand DystoniaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 46 patients were recruited in the study using non-probability purposive sampling and were divided randomly into two equal groups; control and experimental group, by sealed envelope method. The experimental group received botulinum toxin A followed by task specific training, while the control group received only task-specific training for 12 weeks. Data was collected at baseline, after 4 weeks, 8 weeks and 12 weeks by using upper extremity items of Motor Assessment Scale and Fugl Meyer Assessment scale of upper limb, Stroke specific quality of Life, Arm dystonia Disability scale and WOLF Motor function test.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isra University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Umar, Isra University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664375
- Sponsor's protocol ID
- IIRS-IUISB/PHD/008
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Physiotherapy And Botulinum Toxin Type-A In Improving Functional Outcomes In Upper Limb Focal Dystonia Among Post Stroke Patients
- ClinicalTrials.gov ID
- NCT03664375
- Acronym / sponsor ID
- IIRS-IUISB/PHD/008
- Conditions
- Focal Hand Dystonia
- Keywords
- Dystonia Task-specific training Botulinum toxin type A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Isra UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Sep 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.
This study was conducted to assess the combine role of Physiotherapy by providing task specific trainings and Botulinum Toxin Type A in improving the functional outcomes of upper limb in post stroke patients with focal hand dystonia.
Detailed description
Post-stroke hemiparesis, with dystonia, is a major cause of disability. Dystonia can hinder the functional activities making patient dependent on others for performance of daily living activities. Dystonia not only limits the physical activity of the patient but also affects their quality of life significantly. Various treatment protocols have been used in the literature for treatment of focal hand dystonia in the past including deep brain stimulation, kinesio taping, sensory oriented training, splinting, extracorporeal shock wave therapy and botox. Out of these Botox has gained much importance but it results only in improving the passive range of motion and has no consensus in improving the active range of motion and functional independence of the patient. The current study was planned to determine the effects of botulinum toxin type A combined with task-specific therapy, for post-stroke focal dystonia of upper limb.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 46 patients were recruited in the study using non-probability purposive sampling and were divided randomly into two equal groups; control and experimental group, by sealed envelope method. The experimental group received botulinum toxin A followed by task specific training, while the control group received only task-specific training for 12 weeks. Data was collected at baseline, after 4 weeks, 8 weeks and 12 weeks by using upper extremity items of Motor Assessment Scale and Fugl Meyer Assessment scale of upper limb, Stroke specific quality of Life, Arm dystonia Disability scale and WOLF Motor function test.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Botulinum toxin type A, Other: Task Specific TrainingThe experimental group received botulinum toxin type A. After one week of Botox administration, a specially made task specific training program was started for these patients. It was provided for a duration of one hour and for three times per week for a total of 12 weeks by a trained physiotherapist. |
| Control Group | Placebo comparator | Other: Task Specific TrainingThe control group received only task specific training program with the same protocol as for the experimental group; for a duration of one hour and for three times per week up to a total of 12 weeks by a trained physiotherapist |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients having first episode of unilateral stroke
- At least 6 months of post stroke duration presenting with post stroke focal dystonia of the upper limb.
- No previous exposure of the affected hand of Botox.
- Reduced upper limb functions
- Both genders will be included equally.
Key exclusion criteria (8 listed)
- Significant speech or cognitive impairment which impedes the ability to perform the assessment.
- Other significant upper limb impairment e.g. fracture or frozen shoulder within 6 months.
- Severe arthritis, amputation, evidence of fixed contracture, pregnancy or lactating womens.
- Other diagnosis likely to interfere with rehabilitation or outcome assessments, e.g. blind, malignancy,
- Other conditions which may contribute to upper limb spasticity, e.g. multiple sclerosis, cerebral palsy.
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 |
|---|---|---|
| Botulinum toxin type AAll patients in the experimental group received a BoNT-A injection. The injected total dose for individual patient in the experimental group was 100 units which is equivalent to approximately 300-500 Units of Dysport (the other type of BoNT-A available). The Botox was injected by the neurophysician intramuscularly using insulin U100 syringe and determination of muscles for injection was assessed clinically. | Other | Experimental Group |
| Task Specific TrainingTask specific training is the repetition of a specific task until expertise is reached. More challenging tasks are added as a means of progression | Other | Control Group, Experimental Group |
Primary outcome
Action Research Arm Test (ARAT):
Time frame: 12 weeks
It assessed specific changes in limb function by 19 items grouped in four subscales. The total score ranged from 0 to 57. The lower score indicated no movement and upper score indicated normal performance of the patient.
MOTOR ASSESSMENT SCALE (MAS)
Time frame: 12 weeks
It was a performance-based scale, based on a task-oriented approach to evaluate and assesses performance of functional tasks rather than isolated patterns of movement. All items were assessed using a 7-point scale from 0 - 6. A score of 6 indicated optimal motor behavior.
WOLF MOTOR FUNCTION TEST (WMFT)
Time frame: 12 weeks
It quantified motor ability through timed functional tasks. It used a 6-point ordinal scale with "0" = "does not attempt with the involved arm" to "5" = movement appears to be normal."
FUGL- MEYER ASSESSMENT TEST
Time frame: 12 weeks
It was a performance-based impairment index to measure motor functioning. The total score possible was from 0 - 66, with higher function showing the improved level of independence
2 secondary outcomes
Severity Of Dystonia
Time frame: 12 weeks
Stroke Specific Quality Of Life
Time frame: 12 weeks
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 10 Sep 2018.
- Individual participant dataSharing planned: Yes
Related trials for Focal Hand Dystonia
Active, not recruitingPhase 1/2
Deep Brain Stimulation Surgery for Focal Hand Dystonia
Dystonia, Focal Dystonia
Not yet recruiting
VTS Sensorimotor Neuromodulation in WC
Writer's Cramp, Dystonias
Active, not recruiting
Accelerated TMS for Focal Hand Dystonia
Isolated Focal Hand Dystonia
RecruitingPhase 3
IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia
Focal Hand Dystonia
Recruiting
MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)
Task-Specific Focal Dystonia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin type A and Task Specific Training in people with Focal Hand Dystonia, run by Isra University.
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 5 inclusion and 8 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 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Action Research Arm Test (ARAT): (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2018.