Upper Limb SpasticityORTHOXNCT02888548
Randomised, Evaluation-blinded, Crossover, Controlled Study Assessing Dynamic Hand Splinting in Adults With Post-stroke Hemiplegia (Orthox)
A study testing botulinum toxins (Dysport°) alone and orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combined in people with Upper Limb Spasticity, run by CHU de Reims at 1 site in France.
Trial summary
Upper limb spasticity is currently mainly managed with local toxin treatments. Recent studies suggested combining botulinum toxin injections with splinting to optimise rehabilitation in spastic patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Upper Limb Spasticity
- What is being tested?
- botulinum toxins (Dysport°) alone and orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combined
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2016to Jun 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years old
- Male or female
- Ischemic or haemorrhagic stroke more than 6 months ago
- Upper limb spasticity defined by:
- Modified Ashworth Scale (MAS) score > 1
- Disability Assessment Scale (DAS) score > 2
Show all 20Show fewer
- Spasticity angle (Tardieu) > 10°
- Patient's written informed consent
- History of botulinum toxin treatment
- Non inclusion criteria:
- Major limitation of passive range of motion in the elbow, wrist and fingers, preventing splinting:
- Maximum passive extension of the elbow < 150°
- Maximum passive extension of the wrist < 70°
- Maximum passive extension of the fingers < 70°
- Local skin complication preventing splinting (allergy)
- Behavioural disorder preventing splinting
- Adults falling under the Adult Protection Act or unable to give their consent (article L-1121-8 of the French Public Health Code), persons deprived of their liberty or hospitalised without their consent (article L-1121-6 of the French Public Health Code), and pregnant or breastfeeding women (article L-1121-5 of the French Public Health Code).
- Botulinum toxin injections administered less than 4 months from inclusion.
- Contraindications to botulinum toxin (breastfeeding, myasthenia, aminosid, hypersensibility to botulinum toxin or related compounds).
- Concomitant participation in another biomedical study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Evaluation-blinded, Crossover, Controlled Study Assessing the Antispastic Efficacy and Safety of Dynamic Night Hand Splinting in Adults With Post-stroke Hemiplegia Treated by Botulimum Toxin (Dysport®) - (a Pilot Study)
Upper limb spasticity is currently mainly managed with local toxin treatments. Recent studies suggested combining botulinum toxin injections with splinting to optimise rehabilitation in spastic patients. However, one study focused exclusively on lower limb spasticity, the second on elbow flexor hypertonia, and the last on wrist and finger spasticity in children.
A study was performed in adult patients with upper limb spasticity treated with botulinum toxin injections used as primary objective the tolerance for dynamic splinting. The authors noted that the need for botulinum toxin was reduced in 2 patients out of 6. No study has been conducted to date on the splinting + toxin combination in adults.
Read more
Another study showed that stretching sessions over 2 weeks of a muscle just given botulinum toxin helped improve the toxin's efficacy 2, 6 and 12 weeks after the injection. For this reason, rehabilitation teams routinely prescribe 10 sessions of physiotherapy for 15 days after botulinum treatment.
Based on this principle, we hypothesise that dynamic night splinting applied just after botulinum toxin treatment may also increase the toxin's efficacy. We chose a dynamic splint providing continuous stretching of the wrist and fingers in extension whilst allowing active flexion. Night splinting is thought to promote optimal functional use of the paretic upper limb during the day and thus prevent learned non-use, which could worsen the spasticity.
Each patient will receive treatment cycles, whose results will be compared, so that each patient will act as his/her own control. The evaluation will be based on the Tardieu scale chosen for its greater inter-individual reproducibility and greater reliability to measure spasticity.
The degree of extension of wrist and fingers provided by the splint will be adjusted to the patient's clinical condition with the elastic tensioners. The purpose of the splint is to maintain the stretch beyond the Tardieu spasticity angle at fast speed (V3) without reaching maximum extension, which could be harmful.
This protocol is designed to determine whether dynamic night hand splinting combined with botulinum toxin injections will improve botulinum antispastic efficacy in adults with brain damage.
Read the detailed description
This prospective, multicentre, randomised, evaluation-blinded, crossover, pilot study, will include different treatment cycles: a control cycle (toxin alone) and a study cycle (toxin + splinting).
It will be conducted in two sites: CHU de Reims and UGECAM de Charleville Mézières.
The study population will include patients with upper limb spasticity associated with functional impairment and/or pain. To be included, the patients must be non-naïve to botulinum toxin, with a period of at least 4 months since the last toxin injections.
Each patient will be given botulinum toxin injections in the hypertonic muscles of his/her upper limb at the beginning of each cycle, i.e. on D0 Phase 1 (D0P1) and D0 Phase 2 (D0P2). This means each patient will receive two sets of injections at 5-month interval for the whole duration of the study.
- If the effect of the toxin is still present at 5 months (W20), the visit for the following cycle may be delayed to ensure that both cycles are comparable (as per routine practice).
- If the effect is still present at the end of the second cycle, the patient follow-up will be extended until the end of the effect.
As this is the first study of its type, the required number of subjects cannot be calculated and the decision was taken to conduct a pilot study. The required number of patients has been set at 30 for reasons of clinical relevance and study site capacity.
The patients will be randomised centrally into two arms of 15 patients each:
- Arm A: control cycle (toxin alone) followed by study cycle (toxin + splinting)
- Arm B: study cycle (toxin + splinting) followed by control cycle (toxin alone) The second set of toxin injections will be performed 5 months after the first set. As the effect of the toxin lasts 12 to 20 weeks maximum, this interval ensures that the effect of the first injections will have worn off before the second set of injections is given.
Botulinum toxin will be administered under electrical stimulation guidance to improve the accuracy of the injections in the muscles. Dysport® doses will be adjusted to the muscle group being treated.
The post-injection rehabilitation protocol will be identical for both cycles, and include 10 sessions of physiotherapy to stretch the injected muscles (as per routine practice). The prescription of these sessions will be standardised. These daily sessions will start the day following the botulinum injections, and continue 5 times a week for 2 weeks for both treatment phases.
For the study cycle, the splint will be worn only at night (8.00 pm to 8.00 am) for 4 weeks, starting on the first evening after the toxin injection.
Any previous and on-going drug treatment will also be recorded. Concomitant oral antispastic treatments will be authorised provided they were initiated prior to the patient's inclusion in the study, and that dosage regimens remain unchanged.
The investigator performing the evaluations will be blinded to the treatment cycle, i.e. he/she will not know which treatment cycle the patient is currently in. Therefore, the evaluating, injecting and splint-referring physicians will be three different people. To limit potential biases, these 3 persons will remain the same during all the study for all the patients included.
- Conditions
- Upper Limb Spasticity
- Being tested
- botulinum toxins (Dysport°) alone, orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combined
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxins (Dysport°) aloneProcedure or surgery
botulinum toxins (Dysport°) alone
orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combinedProcedure or surgery
orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combined
| Study group | Role | What they receive |
|---|---|---|
| Arm cross over 1 | Experimental | botulinum toxins alone then botulinum toxins + orthos Receives: Procedure: botulinum toxins (Dysport°) alone; Procedure: orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combined |
| Arm cross over 2 | Experimental | botulinum toxins + orthosis then botulinum toxins alone Receives: Procedure: botulinum toxins (Dysport°) alone; Procedure: orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combined |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the angle variation in degrees measured at fast speed V3 on the Tardieu Scale from W4 to D0 between the control cycle (toxin alone) and the splinting cycle (toxin + splint), in a given patient (ie W4-D0 versus W24-W20)
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study start22 Apr 2016
- Primary completion18 May 2016
- Study completionJun 2021
Why it stopped: unsuitable method
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888548
- Sponsor's protocol ID
- PO14104*
- Acronym
- ORTHOX
- Status last verified
- Jun 2021
- First submitted
- 30 Aug 2016
- Last updated
- 11 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Evaluation-blinded, Crossover, Controlled Study Assessing the Antispastic Efficacy and Safety of Dynamic Night Hand Splinting in Adults With Post-stroke Hemiplegia Treated by Botulimum Toxin (Dysport®) - (a Pilot Study)
- ClinicalTrials.gov ID
- NCT02888548
- Acronym / sponsor ID
- ORTHOX / PO14104*
- Conditions
- Upper Limb Spasticity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unsuitable method
- Enrolment
- 1 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 22 Apr 2016 (actual)
- Primary completion
- 18 May 2016 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 5 Sep 2016 (estimated)
- 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.
Upper limb spasticity is currently mainly managed with local toxin treatments. Recent studies suggested combining botulinum toxin injections with splinting to optimise rehabilitation in spastic patients. However, one study focused exclusively on lower limb spasticity, the second on elbow flexor hypertonia, and the last on wrist and finger spasticity in children.
A study was performed in adult patients with upper limb spasticity treated with botulinum toxin injections used as primary objective the tolerance for dynamic splinting. The authors noted that the need for botulinum toxin was reduced in 2 patients out of 6. No study has been conducted to date on the splinting + toxin combination in adults.
Another study showed that stretching sessions over 2 weeks of a muscle just given botulinum toxin helped improve the toxin's efficacy 2, 6 and 12 weeks after the injection. For this reason, rehabilitation teams routinely prescribe 10 sessions of physiotherapy for 15 days after botulinum treatment.
Based on this principle, we hypothesise that dynamic night splinting applied just after botulinum toxin treatment may also increase the toxin's efficacy. We chose a dynamic splint providing continuous stretching of the wrist and fingers in extension whilst allowing active flexion. Night splinting is thought to promote optimal functional use of the paretic upper limb during the day and thus prevent learned non-use, which could worsen the spasticity.
Each patient will receive treatment cycles, whose results will be compared, so that each patient will act as his/her own control. The evaluation will be based on the Tardieu scale chosen for its greater inter-individual reproducibility and greater reliability to measure spasticity.
The degree of extension of wrist and fingers provided by the splint will be adjusted to the patient's clinical condition with the elastic tensioners. The purpose of the splint is to maintain the stretch beyond the Tardieu spasticity angle at fast speed (V3) without reaching maximum extension, which could be harmful.
This protocol is designed to determine whether dynamic night hand splinting combined with botulinum toxin injections will improve botulinum antispastic efficacy in adults with brain damage.
Detailed description
This prospective, multicentre, randomised, evaluation-blinded, crossover, pilot study, will include different treatment cycles: a control cycle (toxin alone) and a study cycle (toxin + splinting).
It will be conducted in two sites: CHU de Reims and UGECAM de Charleville Mézières.
The study population will include patients with upper limb spasticity associated with functional impairment and/or pain. To be included, the patients must be non-naïve to botulinum toxin, with a period of at least 4 months since the last toxin injections.
Each patient will be given botulinum toxin injections in the hypertonic muscles of his/her upper limb at the beginning of each cycle, i.e. on D0 Phase 1 (D0P1) and D0 Phase 2 (D0P2). This means each patient will receive two sets of injections at 5-month interval for the whole duration of the study.
- If the effect of the toxin is still present at 5 months (W20), the visit for the following cycle may be delayed to ensure that both cycles are comparable (as per routine practice).
- If the effect is still present at the end of the second cycle, the patient follow-up will be extended until the end of the effect.
As this is the first study of its type, the required number of subjects cannot be calculated and the decision was taken to conduct a pilot study. The required number of patients has been set at 30 for reasons of clinical relevance and study site capacity.
The patients will be randomised centrally into two arms of 15 patients each:
- Arm A: control cycle (toxin alone) followed by study cycle (toxin + splinting)
- Arm B: study cycle (toxin + splinting) followed by control cycle (toxin alone) The second set of toxin injections will be performed 5 months after the first set. As the effect of the toxin lasts 12 to 20 weeks maximum, this interval ensures that the effect of the first injections will have worn off before the second set of injections is given.
Botulinum toxin will be administered under electrical stimulation guidance to improve the accuracy of the injections in the muscles. Dysport® doses will be adjusted to the muscle group being treated.
The post-injection rehabilitation protocol will be identical for both cycles, and include 10 sessions of physiotherapy to stretch the injected muscles (as per routine practice). The prescription of these sessions will be standardised. These daily sessions will start the day following the botulinum injections, and continue 5 times a week for 2 weeks for both treatment phases.
For the study cycle, the splint will be worn only at night (8.00 pm to 8.00 am) for 4 weeks, starting on the first evening after the toxin injection.
Any previous and on-going drug treatment will also be recorded. Concomitant oral antispastic treatments will be authorised provided they were initiated prior to the patient's inclusion in the study, and that dosage regimens remain unchanged.
The investigator performing the evaluations will be blinded to the treatment cycle, i.e. he/she will not know which treatment cycle the patient is currently in. Therefore, the evaluating, injecting and splint-referring physicians will be three different people. To limit potential biases, these 3 persons will remain the same during all the study for all the patients included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm cross over 1 | Experimental | Procedure: botulinum toxins (Dysport°) alone, Procedure: orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combinedbotulinum toxins alone then botulinum toxins + orthos |
| Arm cross over 2 | Experimental | Procedure: botulinum toxins (Dysport°) alone, Procedure: orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combinedbotulinum toxins + orthosis then botulinum toxins alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age between 18 and 80 years old
- Male or female
- Ischemic or haemorrhagic stroke more than 6 months ago
- Upper limb spasticity defined by:
- Modified Ashworth Scale (MAS) score > 1
Key exclusion criteria (0 listed)
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 toxins (Dysport°) alonebotulinum toxins (Dysport°) alone | Procedure or surgery | Arm cross over 1, Arm cross over 2 |
| orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combinedorthosis (Saebo Strech°) + botulinum toxins (Dysport°) combined | Procedure or surgery | Arm cross over 1, Arm cross over 2 |
Primary outcome
Comparison of the angle variation in degrees measured at fast speed V3 on the Tardieu Scale from W4 to D0 between the control cycle (toxin alone) and the splinting cycle (toxin + splint), in a given patient (ie W4-D0 versus W24-W20)
Time frame: up to 24 weeks
Results and safety
The study was stopped early (reason given: unsuitable method). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
Related trials for Upper Limb Spasticity
RecruitingPhase 1
Shockwave for Elbow and Wrist Spasticity in People With Spinal Cord Injury
Spinal Cord Injury, Spasticity
Active, not recruitingPhase 3
Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury
Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
Active, not recruiting
FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity
Stroke, Spasticity, Muscle
Not yet recruiting
Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy.
Cerebral Palsy Spastic Hemiplegic, Functionnal Neurological Disorder
RecruitingPhase 2
A Pilot Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, in Participants With Post-Stroke Spasticity (The STIPS Study)
Post-Stroke Spasticity
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing botulinum toxins (Dysport°) alone and orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combined in people with Upper Limb Spasticity, run by CHU de Reims at 1 site in France.
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 20 inclusion and 0 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: stopped early, as of the sponsor's last update on 11 Jun 2021. 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 France. 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 was stopped early (reason given: unsuitable method). Results are not available in the source record.
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?
Comparison of the angle variation in degrees measured at fast speed V3 on the Tardieu Scale from W4 to D0 between the control cycle (toxin alone) and the splinting cycle (toxin + splint), in a given patient (ie W4-D0 versus W24-W20) (time frame: up to 24 weeks). 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 11 Jun 2021.