Upper Extermity SpasticityNCT04670783
Surgery and Neuroablative Procedures in Spasticity
An observational study of Upper Extermity Spasticity and Multidisciplinary Approach, run by Vancouver Island Health Authority at 1 site in Canada.
Trial summary
For many patients with spasticity, traditional therapies have not achieved maximal outcomes. Due to common complaints such as pain, limb positioning and hygiene concerns, there has been an increase demand for other adjunctive therapies like surgeries and other interventions. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Upper Extermity Spasticity, Multidisciplinary Approach, Novel Algorithm
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 63 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2020to 30 May 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any adult patient with upper limb spasticity who has been triaged to have surgery or neuroablative procedure after undergoing a successful DNB.
Who may be able to join
- Adult patient ≥ 18 years old, with upper extremity spasticity causing functional impairment.
- Patients that have plateaued in outcomes in which the clinical examination suggests further interventions can be trialed.
- The clinical examination, including a V1 (maximal passive stretch) and V3 (Fast catch) on upper extremity examination that demonstrates further passive or active range may be possible, versus if contracture must be managed. For example, a fisted hand that can be forced open. This includes factors such as fluctuating tone or clonus interfering with the assessment.
- The patient undergoes a diagnostic nerve block to determine if there is reducible spasticity in the muscle versus contracture.
- The patient has been offered a neuroablative procedure or surgery and has elected to undergo the procedure. The patient has consented to undergo the said procedure.
Who cannot join
- Patients where no consent or Assent is obtained
- Unable to attend treatment schedule,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring the Efficacy of Surgical and Percutaneous Neuroablative Procedures in the Management of Plateaued or Refractory Upper-extremity Spasticity.
For many patients with spasticity, traditional therapies have not achieved maximal outcomes. Due to common complaints such as pain, limb positioning and hygiene concerns, there has been an increase demand for other adjunctive therapies like surgeries and other interventions. This spasticity multidisciplinary clinic consisting of a physiatrist, plastic surgeon and anesthesiologist is performing a novel approach to refractory spasticity to triage and designed a treatment plan for them as routine medical care. This study will document the efficacy of this novel designed multidisciplinary approaches for intervention in complex spasticity patients, and will develop a decision-making algorithm in spasticity including both traditional treatment (i.e. botulinum toxin , bracing) and novel treatments(i.e. neurectomy , cryoneurotomy).
Read the detailed description
Many patients continue to live with disabling spasticity that negatively affects their health, independence and quality of life. For these patients, traditional therapies such as bracing, medications, and botulinum toxin have not achieved maximal outcomes. Up to one-quarter of physicians have noted to be limited by the maximal dosage of botulinum toxin allowed in their country. Due to common complaints of pain, difficulty with limb positioning, and hygiene concerns there has been an increase in demand for novel adjunctive therapies, including surgery, to improve patient outcomes.
The deisgned triage pathway is based on the diagnostic lidocaine nerve block (DNB), which is already using in Franco-European studies and has been accepted as academic abstract at the Canadian Association of Physical Medicine and Rehabilitation Annual Meeting in Gatineau Quebec in 2019. In this approach, patients are triaged for intervention based on their responses to DNB, which is applying local anesthesia to a selected nerve branch. Also the investigators of this study who have created Canada's first interdisciplinary spasticity clinic consisting of a physiatrist, plastic surgeon and anesthesiologist are working to bring the world-leading spasticity interventions to Canada and developing Canadian techniques. This includes cryoneurotomy and selective microfascicular neurectomy. Both of these techniques have been developed in this multidisciplinary clinic and in the past three years and have been published as journal articles, academic posters or presented at international congresses.This research is a pilot study to test the present current triage and treatment pathways. This study will evaluate the patients with upper limb spasticity who are going to have any of traditional treatments (i.e. bracing, botulinum toxin) or novel treatments (i.e. cryoneurotomy, tenotomy, neurotomy) as their standard medical cares. All these assessments are parts of their standard evaluations and the available data will be collected for this study. These data include their range of motions, spasticity grades, upper limb function, pain, satisfaction and injected botulinum toxin dosage. These data will be used to document the efficacy of this approach by comparing these measurements that are already done for their standard clinical care. Also, the final result will be helpful to create a Canadian algorithm to approach patients with refractory upper limb spasticity.
- Conditions
- Upper Extermity Spasticity, Multidisciplinary Approach, Novel Algorithm, Diagnostic Nerve Block, Surgery, Percutaneous Neuroablative Procedures
- Being tested
- Surgery
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Also called Percutaneous neuroablation
Orthopedic surgery (i.e. tenotomy, tendon transfer) or percutaneous neuroablative procedures (i.e. cryoneurotomy) which will be done for upper limb refractory spasticity after being triaged by DNB.
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of changes in spasticity as assessed by Modified Ashworth Scale from baseline and in 1, 3, 6, 9 and 12 months after the intervention.
The test will be done by the trained assistant which is not enrolled in providing medical care. The scale has 5 grades and based on severity of spasticity the examiner will assign a number to each tested movement. The grades are shown as 0, 1, 1+, 2, 3, 4. In grade 0 patient shows no spasticity , while grade 4 means maximum spasticity and the affected limb is rigid in flexion or extention.
Measured: up to 12 months after intervention
Degree of changes in range of motion of tested joints as assessed by Tardieu Scale from base line and in 1, 3, 6, 9 and 12 months.
The maximum of passive range of motion in slow movement(V1) and degree of catch in speed (V3) and active range of motion will be measured by goniometer.
Measured: up to 12 months
Upper limb function changes as assessed by Disabilities of the Arm, Shoulder and Hand questionnaire ( DASH questionnaire)(2006).
It is a self-administered questionnaire that participants will be asked to fill out at baseline and in 1, 3, 6, 9 and 12 months. Final score will be calculated based on the provided formula and will be between (0) , which means patient has no difficulty at all and (100) which means the worst outcome.
Measured: up to 12 months
Patients satisfaction in achieving their goals after the procedure as assessed by Patients satisfaction in achieving their goals after the procedure as assessed by Goal Attainment Scale.
Patients satisfaction in achieving their goals after the procedure as assessed by Goal Attainment Scale38. Based on this scale participants will be asked for 3 main goals that they desire to achieve after the intervention. The baseline score will be (-1) and they will be interviewed again at 1, 3, 6, 9 and 12 months, to record how they reported their achievement. The scores of (-2), (-0.5), (0), (+1) and (+2) will be assigned if they feel that their condition is worst than before, better but not as good as expected, as expected, better than expected and much better than expected. All goals will be weighted equally, and final score will be calculated based on the available formula, in each session. The higher score is presenting of better outcome
Measured: up to 12 months after procedure
Secondary outcomes (6)
Upper limb function changes as assessed by Box and Block test.
Participants will be in sitting position and will be asked to move the cubes from one part to the other part in 1 minute.The test will be done in baseline and in 1, 3,6, 9 and 12 months.
Measured: up to 12 months after procedure.
Changes in pain as assessed by Brief Pain Inventory Questionnaire.
This is a self-administered questionnaire that will be provided for participants for filing out at baseline and in 1, 3, 6, 9 and 12 months after the intervention.The Patient will ask to answer each question by choosing a number between 0 to 10, and the final score is calculating by adding these numbers together and then divided by 4. The result will show the severity of patient pain out of 10. (0 means no pain and 10 means the worst pain that can be imagine)
Measured: up to 12 months
Changes in hand resting position as assessed by Keenan Scale. (the name of the physician that first described that in 1987)
Changes in the Hand resting position as assessed by Keenan Scale. Participants will be assessed by an independent examiner and based on available scale their hand position will be graded. Grade 1 is the minimum deformity while grade 5 Is the maximum deformity which is presented by clenched fist and palmar hygiene problem. The assessment will be done at baseline and in 1, 3, 6, 9 and 12 months.
Measured: 12 months after intervention
Changes in thumb position as assessed by House Scale (The name of physician that first described this classification in 1981).
Changes in thumb deformity (position of thumb in relation to other fi ngers) as assessed by House Scale (1981).Participants will be assessed by an independent examiner and based on available scale their thumb position will be graded between 1 to 4. Grade 1 is the minimum deformity and 4 is the maximum deformity. The assessment will be done at baseline and in 1, 3, 6, 9 and 12 months.
Measured: 12 months after the procedure
Changes in hand function as assessed by House Functional Scale ( the name of the physician that first described this scale in 1981).
The test will be done by an independent examiner and participants will be asked to pick a cube on the table while they are in a sitting position. Based on the available scale (o= No movement and 8= spontaneous use, complete) their hand function will be graded in baseline, 1,3,6,9 and 12 months after intervention.
Measured: up to 12 months after intervention
Changes in hand grip strength as assessed by dynamometer from baseline to 1,3,6,9 and 12 months.
The test will be done by Jamar Dynamometer and will be recorded as kilogram.
Measured: up to 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start15 Sep 2020
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Upper Extermity SpasticityStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Vancouver Island Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahdis Hashemi, Vancouver Island Health Authority
- Investigators
- Paul Winston, MD FRCPC, Principal investigator, VIHA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670783
- Sponsor's protocol ID
- H2019-03232
- Status last verified
- Jun 2023
- First submitted
- 17 Nov 2020
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wissel J, Verrier M, Simpson DM, Charles D, Guinto P, Papapetropoulos S, Sunnerhagen KS. Post-stroke spasticity: predictors of early development and considerations for therapeutic intervention. PM R. 2015 Jan;7(1):60-7. doi: 10.1016/j.pmrj.2014.08.946. Epub 2014 Aug 27.
PubMed 25171879Bensmail D, Hanschmann A, Wissel J. Satisfaction with botulinum toxin treatment in post-stroke spasticity: results from two cross-sectional surveys (patients and physicians). J Med Econ. 2014 Sep;17(9):618-25. doi: 10.3111/13696998.2014.925462. Epub 2014 Jun 12.
PubMed 24841450Yelnik AP, Hentzen C, Cuvillon P, Allart E, Bonan IV, Boyer FC, Coroian F, Genet F, Honore T, Jousse M, Fletcher D, Velly L, Laffont I; SOFMER group; SFAR group; Viel E. French clinical guidelines for peripheral motor nerve blocks in a PRM setting. Ann Phys Rehabil Med. 2019 Jul;62(4):252-264. doi: 10.1016/j.rehab.2019.06.001. Epub 2019 Jun 13.
PubMed 31202956Winston P, Mills PB, Reebye R, Vincent D. Cryoneurotomy as a Percutaneous Mini-invasive Therapy for the Treatment of the Spastic Limb: Case Presentation, Review of the Literature, and Proposed Approach for Use. Arch Rehabil Res Clin Transl. 2019 Oct 17;1(3-4):100030. doi: 10.1016/j.arrct.2019.100030. eCollection 2019 Dec.
PubMed 33543059Winston P, Krauss E, Vincent D. Cryoneurotomy of the bilateral lateral pectoral nerves in a quadriplegic patient with spasticity, a novel approach. ISPRM 2020 Poster. 2020.
Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.
PubMed 8773720House JH, Gwathmey FW, Fidler MO. A dynamic approach to the thumb-in palm deformity in cerebral palsy. J Bone Joint Surg Am. 1981 Feb;63(2):216-25.
PubMed 7462278Winston P, MacRae F, Rajapakshe S, Morrissey I, Boissonnault E, Vincent D, Hashemi M. Analysis of Adverse Effects of Cryoneurolysis for the Treatment of Spasticity. Am J Phys Med Rehabil. 2023 Nov 1;102(11):1008-1013. doi: 10.1097/PHM.0000000000002267. Epub 2023 Apr 24.
PubMed 37104641
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Efficacy of Surgical and Percutaneous Neuroablative Procedures in the Management of Plateaued or Refractory Upper-extremity Spasticity.
- ClinicalTrials.gov ID
- NCT04670783
- Acronym / sponsor ID
- H2019-03232
- Conditions
- Upper Extermity Spasticity, Multidisciplinary Approach, Novel Algorithm, Diagnostic Nerve Block, Surgery, Percutaneous Neuroablative Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Vancouver Island Health AuthorityUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 17 Dec 2020 (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.
For many patients with spasticity, traditional therapies have not achieved maximal outcomes. Due to common complaints such as pain, limb positioning and hygiene concerns, there has been an increase demand for other adjunctive therapies like surgeries and other interventions. This spasticity multidisciplinary clinic consisting of a physiatrist, plastic surgeon and anesthesiologist is performing a novel approach to refractory spasticity to triage and designed a treatment plan for them as routine medical care. This study will document the efficacy of this novel designed multidisciplinary approaches for intervention in complex spasticity patients, and will develop a decision-making algorithm in spasticity including both traditional treatment (i.e. botulinum toxin , bracing) and novel treatments(i.e. neurectomy , cryoneurotomy).
Detailed description
Many patients continue to live with disabling spasticity that negatively affects their health, independence and quality of life. For these patients, traditional therapies such as bracing, medications, and botulinum toxin have not achieved maximal outcomes. Up to one-quarter of physicians have noted to be limited by the maximal dosage of botulinum toxin allowed in their country. Due to common complaints of pain, difficulty with limb positioning, and hygiene concerns there has been an increase in demand for novel adjunctive therapies, including surgery, to improve patient outcomes.
The deisgned triage pathway is based on the diagnostic lidocaine nerve block (DNB), which is already using in Franco-European studies and has been accepted as academic abstract at the Canadian Association of Physical Medicine and Rehabilitation Annual Meeting in Gatineau Quebec in 2019. In this approach, patients are triaged for intervention based on their responses to DNB, which is applying local anesthesia to a selected nerve branch. Also the investigators of this study who have created Canada's first interdisciplinary spasticity clinic consisting of a physiatrist, plastic surgeon and anesthesiologist are working to bring the world-leading spasticity interventions to Canada and developing Canadian techniques. This includes cryoneurotomy and selective microfascicular neurectomy. Both of these techniques have been developed in this multidisciplinary clinic and in the past three years and have been published as journal articles, academic posters or presented at international congresses.This research is a pilot study to test the present current triage and treatment pathways. This study will evaluate the patients with upper limb spasticity who are going to have any of traditional treatments (i.e. bracing, botulinum toxin) or novel treatments (i.e. cryoneurotomy, tenotomy, neurotomy) as their standard medical cares. All these assessments are parts of their standard evaluations and the available data will be collected for this study. These data include their range of motions, spasticity grades, upper limb function, pain, satisfaction and injected botulinum toxin dosage. These data will be used to document the efficacy of this approach by comparing these measurements that are already done for their standard clinical care. Also, the final result will be helpful to create a Canadian algorithm to approach patients with refractory upper limb spasticity.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any adult patient with upper limb spasticity who has been triaged to have surgery or neuroablative procedure after undergoing a successful DNB.
Key inclusion criteria (5 listed)
- Adult patient ≥ 18 years old, with upper extremity spasticity causing functional impairment.
- Patients that have plateaued in outcomes in which the clinical examination suggests further interventions can be trialed.
- The clinical examination, including a V1 (maximal passive stretch) and V3 (Fast catch) on upper extremity examination that demonstrates further passive or active range may be possible, versus if contracture must be managed. For example, a fisted hand that can be forced open. This includes factors such as fluctuating tone or clonus interfering with the assessment.
- The patient undergoes a diagnostic nerve block to determine if there is reducible spasticity in the muscle versus contracture.
- The patient has been offered a neuroablative procedure or surgery and has elected to undergo the procedure. The patient has consented to undergo the said procedure.
Key exclusion criteria (2 listed)
- Patients where no consent or Assent is obtained
- Unable to attend treatment schedule,
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 |
|---|---|---|
| SurgeryAlso: Percutaneous neuroablationOrthopedic surgery (i.e. tenotomy, tendon transfer) or percutaneous neuroablative procedures (i.e. cryoneurotomy) which will be done for upper limb refractory spasticity after being triaged by DNB. | Procedure or surgery | – |
Primary outcome
Degree of changes in spasticity as assessed by Modified Ashworth Scale from baseline and in 1, 3, 6, 9 and 12 months after the intervention.
Time frame: up to 12 months after intervention
The test will be done by the trained assistant which is not enrolled in providing medical care. The scale has 5 grades and based on severity of spasticity the examiner will assign a number to each tested movement. The grades are shown as 0, 1, 1+, 2, 3, 4. In grade 0 patient shows no spasticity , while grade 4 means maximum spasticity and the affected limb is rigid in flexion or extention.
Degree of changes in range of motion of tested joints as assessed by Tardieu Scale from base line and in 1, 3, 6, 9 and 12 months.
Time frame: up to 12 months
The maximum of passive range of motion in slow movement(V1) and degree of catch in speed (V3) and active range of motion will be measured by goniometer.
Upper limb function changes as assessed by Disabilities of the Arm, Shoulder and Hand questionnaire ( DASH questionnaire)(2006).
Time frame: up to 12 months
It is a self-administered questionnaire that participants will be asked to fill out at baseline and in 1, 3, 6, 9 and 12 months. Final score will be calculated based on the provided formula and will be between (0) , which means patient has no difficulty at all and (100) which means the worst outcome.
Patients satisfaction in achieving their goals after the procedure as assessed by Patients satisfaction in achieving their goals after the procedure as assessed by Goal Attainment Scale.
Time frame: up to 12 months after procedure
Patients satisfaction in achieving their goals after the procedure as assessed by Goal Attainment Scale38. Based on this scale participants will be asked for 3 main goals that they desire to achieve after the intervention. The baseline score will be (-1) and they will be interviewed again at 1, 3, 6, 9 and 12 months, to record how they reported their achievement. The scores of (-2), (-0.5), (0), (+1) and (+2) will be assigned if they feel that their condition is worst than before, better but not as good as expected, as expected, better than expected and much better than expected. All goals will be weighted equally, and final score will be calculated based on the available formula, in each session. The higher score is presenting of better outcome
6 secondary outcomes
Upper limb function changes as assessed by Box and Block test.
Time frame: up to 12 months after procedure.
Changes in pain as assessed by Brief Pain Inventory Questionnaire.
Time frame: up to 12 months
Changes in hand resting position as assessed by Keenan Scale. (the name of the physician that first described that in 1987)
Time frame: 12 months after intervention
Changes in thumb position as assessed by House Scale (The name of physician that first described this classification in 1981).
Time frame: 12 months after the procedure
Changes in hand function as assessed by House Functional Scale ( the name of the physician that first described this scale in 1981).
Time frame: up to 12 months after intervention
Changes in hand grip strength as assessed by dynamometer from baseline to 1,3,6,9 and 12 months.
Time frame: up to 12 months after the intervention
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 5 Jun 2023.
- Background: PubMed 25171879Wissel J, Verrier M, Simpson DM, Charles D, Guinto P, Papapetropoulos S, Sunnerhagen KS. Post-stroke spasticity: predictors of early development and considerations for therapeutic intervention. PM R. 2015 Jan;7(1):60-7. doi: 10.1016/j.pmrj.2014.08.946. Epub 2014 Aug 27.
- Background: PubMed 24841450Bensmail D, Hanschmann A, Wissel J. Satisfaction with botulinum toxin treatment in post-stroke spasticity: results from two cross-sectional surveys (patients and physicians). J Med Econ. 2014 Sep;17(9):618-25. doi: 10.3111/13696998.2014.925462. Epub 2014 Jun 12.
- Background: PubMed 31202956Yelnik AP, Hentzen C, Cuvillon P, Allart E, Bonan IV, Boyer FC, Coroian F, Genet F, Honore T, Jousse M, Fletcher D, Velly L, Laffont I; SOFMER group; SFAR group; Viel E. French clinical guidelines for peripheral motor nerve blocks in a PRM setting. Ann Phys Rehabil Med. 2019 Jul;62(4):252-264. doi: 10.1016/j.rehab.2019.06.001. Epub 2019 Jun 13.
- Background: PubMed 33543059Winston P, Mills PB, Reebye R, Vincent D. Cryoneurotomy as a Percutaneous Mini-invasive Therapy for the Treatment of the Spastic Limb: Case Presentation, Review of the Literature, and Proposed Approach for Use. Arch Rehabil Res Clin Transl. 2019 Oct 17;1(3-4):100030. doi: 10.1016/j.arrct.2019.100030. eCollection 2019 Dec.
- BackgroundWinston P, Krauss E, Vincent D. Cryoneurotomy of the bilateral lateral pectoral nerves in a quadriplegic patient with spasticity, a novel approach. ISPRM 2020 Poster. 2020.
- Background: PubMed 8773720Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.
- Background: PubMed 7462278House JH, Gwathmey FW, Fidler MO. A dynamic approach to the thumb-in palm deformity in cerebral palsy. J Bone Joint Surg Am. 1981 Feb;63(2):216-25.
- Derived from this study: PubMed 37104641Winston P, MacRae F, Rajapakshe S, Morrissey I, Boissonnault E, Vincent D, Hashemi M. Analysis of Adverse Effects of Cryoneurolysis for the Treatment of Spasticity. Am J Phys Med Rehabil. 2023 Nov 1;102(11):1008-1013. doi: 10.1097/PHM.0000000000002267. Epub 2023 Apr 24.
- Individual participant dataSharing planned: No
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.
Paul Winston, MD FRCPC principal investigator
VIHA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Extermity Spasticity and Multidisciplinary Approach, run by Vancouver Island Health Authority at 1 site in Canada.
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 2 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 5 Jun 2023. 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 Canada. 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?
Degree of changes in spasticity as assessed by Modified Ashworth Scale from baseline and in 1, 3, 6, 9 and 12 months after the intervention. (time frame: up to 12 months after intervention). 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?
On the ClinicalTrials.gov record for NCT04670783, which also lists 8 linked publications.
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 5 Jun 2023.