Brain InjuriesPhase 2NCT03008486
Long Term Effects of Soft Splints on Stroke Patients and Patients With Disorders of Consciousness
A Phase 2 study testing Real soft splint (6 cm) in people with Brain Injuries and Disorder of Consciousness, run by Géraldine Martens at 1 site in Belgium.
Trial summary
The purpose of this study is to assess the effects on upper limb spasticity of soft splints worn during three weeks three hours a day by patients with stroke or disorders of consciousness. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Brain Injuries, Disorder of Consciousness, Stroke
- What is being tested?
- Real soft splint (6 cm)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2017to Jun 2019
- Phase
- Phase 2
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Altered state of consciousness according to international criteria since more than three months
- Stable condition
- Ashworth score > 1 for at least one upper limb joint
- Central nervous system injury responsible for the spasticity
- Ashworth score > 1 for at least one upper limb joint
Who cannot join
- Bone fracture/lesion at the upper limbs
- Serious neurological disorder (MMSE > 24) prior to the accident
- Botox injection on the upper limbs in the 6 months preceding the inclusion
- Bone fracture/lesion at the upper limbs
- Serious neurological disorder (MMSE > 24)
- Botox injection on the upper limbs in the 6 months preceding the inclusion
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Centre Hospitalier Neurologique William Lennox
Ottignies, Brabant Wallon, 1340
About this study
The purpose of this study is to assess the effects on upper limb spasticity of soft splints worn during three weeks three hours a day by patients with stroke or disorders of consciousness.
Read the detailed description
Patients with stroke or disorders of consciousness (DOC) are likely to suffer from major muscular troubles such as spasticity. This spasticity may induce pain, loss in range of motion and permanent joint deformities. The aim of this study is to investigate the effects of soft splinting on the hand spasticity in both patients with stroke and patients with disorders of consciousness. The investigators plan to include 100 patients (50 stroke - 50 with DOC) and each subgroup will be divided in two arms: one wearing real soft splints (6 cm diameter) three hours a day for 3 three weeks and the other one wearing 'placebo' splints (1 cm diameter).
Skin condition will be followed by the nursing team during the three weeks. Spasticity, pain and consciousness assessments will be performed at baseline (week 0), after 1 week of treatment (week 1) at the end of the treatment (week 3), 1 week later (week 4), 3 weeks later (week 6) and three months later (week 12).
- Conditions
- Brain Injuries, Disorder of Consciousness, Stroke, Spasticity as Sequela of Stroke, Contracture, Hypertonic Disorder
- Being tested
- Real soft splint (6 cm), Placebo soft splint (1 cm)
- Medical subject headings
- Brain Injuries, Consciousness Disorders, Stroke, Contracture, Central Nervous System Diseases, Pathologic Processes, Craniocerebral Trauma, Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real soft splint (6 cm)Device
Placebo soft splint (1 cm)Device
| Study group | Role | What they receive |
|---|---|---|
| DOC - real | Active comparator | Spastic patients with disorders of consciousness receiving the real soft splint Receives: Device: Real soft splint (6 cm) |
| DOC - placebo | Placebo comparator | Spastic patients with disorders of consciousness receiving the placebo soft splint Receives: Device: Placebo soft splint (1 cm) |
| Stroke - real | Active comparator | Spastic patients stroke receiving the real soft splint Receives: Device: Real soft splint (6 cm) |
| Stroke - placebo | Placebo comparator | Spastic patients stroke receiving the placebo soft splint Receives: Device: Placebo soft splint (1 cm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Modified Ashworth Scale
Spasticity assessment
Measured: Week 0, 1, 3, 4, 6, 12
Change in the Modified Tardieu Scale
Spasticity assessment
Measured: Week 0, 1, 3, 4, 6, 12
Change in the Nociception Coma Scale-Revised
Pain assessment
Measured: Week 0, 1, 3, 4, 6, 12
Change in the Visual Analogue Scale
Pain assessment
Measured: Week 0, 1, 3, 4, 6, 12
Change in the Palm-finger distance
Range of motion assessment
Measured: Week 0, 1, 3, 4, 6, 12
Secondary outcomes (1)
Change in the Coma Recovery Scale-Revised
Consciousness assessment
Measured: Week 0, 1, 3, 4, 6, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Géraldine Martens
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire UCLouvain Namur
- Responsible party
- Sponsor-investigator, Géraldine Martens, University of Liege
- Investigators
- Nicolas Lejeune, Principal investigator, Centre Hospitalier Neurologique William Lennox
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008486
- Sponsor's protocol ID
- 2016/292
- Status last verified
- Sep 2019
- First submitted
- 26 Dec 2016
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effects of Soft Splints on Stroke Patients and Patients With Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT03008486
- Acronym / sponsor ID
- 2016/292
- Conditions
- Brain Injuries, Disorder of Consciousness, Stroke, Spasticity as Sequela of Stroke, Contracture, Hypertonic Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Géraldine MartensUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire UCLouvain Namur
- Study start
- Jan 2017
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 2 Jan 2017 (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.
The purpose of this study is to assess the effects on upper limb spasticity of soft splints worn during three weeks three hours a day by patients with stroke or disorders of consciousness.
Detailed description
Patients with stroke or disorders of consciousness (DOC) are likely to suffer from major muscular troubles such as spasticity. This spasticity may induce pain, loss in range of motion and permanent joint deformities. The aim of this study is to investigate the effects of soft splinting on the hand spasticity in both patients with stroke and patients with disorders of consciousness. The investigators plan to include 100 patients (50 stroke - 50 with DOC) and each subgroup will be divided in two arms: one wearing real soft splints (6 cm diameter) three hours a day for 3 three weeks and the other one wearing 'placebo' splints (1 cm diameter).
Skin condition will be followed by the nursing team during the three weeks. Spasticity, pain and consciousness assessments will be performed at baseline (week 0), after 1 week of treatment (week 1) at the end of the treatment (week 3), 1 week later (week 4), 3 weeks later (week 6) and three months later (week 12).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DOC - real | Active comparator | Device: Real soft splint (6 cm)Spastic patients with disorders of consciousness receiving the real soft splint |
| DOC - placebo | Placebo comparator | Device: Placebo soft splint (1 cm)Spastic patients with disorders of consciousness receiving the placebo soft splint |
| Stroke - real | Active comparator | Device: Real soft splint (6 cm)Spastic patients stroke receiving the real soft splint |
| Stroke - placebo | Placebo comparator | Device: Placebo soft splint (1 cm)Spastic patients stroke receiving the placebo soft splint |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Altered state of consciousness according to international criteria since more than three months
- Stable condition
- Ashworth score > 1 for at least one upper limb joint
- Central nervous system injury responsible for the spasticity
- Ashworth score > 1 for at least one upper limb joint
Key exclusion criteria (6 listed)
- Bone fracture/lesion at the upper limbs
- Serious neurological disorder (MMSE > 24) prior to the accident
- Botox injection on the upper limbs in the 6 months preceding the inclusion
- Bone fracture/lesion at the upper limbs
- Serious neurological disorder (MMSE > 24)
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 |
|---|---|---|
| Real soft splint (6 cm) | Device | DOC - real, Stroke - real |
| Placebo soft splint (1 cm) | Device | DOC - placebo, Stroke - placebo |
Primary outcome
Change in the Modified Ashworth Scale
Time frame: Week 0, 1, 3, 4, 6, 12
Spasticity assessment
Change in the Modified Tardieu Scale
Time frame: Week 0, 1, 3, 4, 6, 12
Spasticity assessment
Change in the Nociception Coma Scale-Revised
Time frame: Week 0, 1, 3, 4, 6, 12
Pain assessment
Change in the Visual Analogue Scale
Time frame: Week 0, 1, 3, 4, 6, 12
Pain assessment
Change in the Palm-finger distance
Time frame: Week 0, 1, 3, 4, 6, 12
Range of motion assessment
1 secondary outcome
Change in the Coma Recovery Scale-Revised
Time frame: Week 0, 1, 3, 4, 6, 12
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 25 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Brain Injuries
Not yet recruitingObservational study
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitationObservational study
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Traumatic Brain Injury
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
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.
Nicolas Lejeune principal investigator
Centre Hospitalier Neurologique William Lennox
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Real soft splint (6 cm) in people with Brain Injuries and Disorder of Consciousness, run by Géraldine Martens at 1 site in Belgium.
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 6 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 25 Sep 2019. 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 Belgium. 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in the Modified Ashworth Scale (time frame: Week 0, 1, 3, 4, 6, 12). The study lists 5 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 25 Sep 2019.