Muscle SpasticityPHYSIOHANDNCT04502927
Measurements of Displacement Amplitude and Angular Velocities During Passive Extension of the Wrist and Hand Complex in Stroke Patients
A study testing Passive extension mobilization of the hand and wrist joints in people with Muscle Spasticity and Stroke, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
Trial summary
The main objective of this monocentric prospective study is to evaluate the amplitudes and angular velocities of extension of the hand and wrist joints during passive mobilization by a physiotherapist in healthy subjects and stroke patients with spastic hands. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Spasticity, Stroke
- What is being tested?
- Passive extension mobilization of the hand and wrist joints
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2020to 18 Mar 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- First stroke diagnosed less than 3 months ago
- Non-functional wrist defined by the Fugl-Meyer Assesment (FMA-EU) upper limb motor subscale with a score ≤45
- Wrist flexor spasticity defined by the Modified Tardieu Scale (MTS) with a rating ≥1
- Written informed consent
- Age ≥ 18 years old
- Written informed consent
Who cannot join
- None
- Eligibility criteria of healthy volunteers:
- None
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
Mulhouse
About this study
The main objective of this monocentric prospective study is to evaluate the amplitudes and angular velocities of extension of the hand and wrist joints during passive mobilization by a physiotherapist in healthy subjects and stroke patients with spastic hands.
Secondary objectives:
- To compare amplitude and angular velocity values between the group of stroke patients and the group of healthy volunteers,
- To compare amplitude and angular velocity values according to the two types of mobilization (i,e, thumb or fifth finger),
- To assess pain due to mobilization in stroke patients.
Read the detailed description
Conduct of research:
The realization of the measures will take place at the GHRMSA rehabilitation department.
After receiving the written consent of the study participant, the physiotherapist will proceed with the passive mobilization of the spastic hand of the stroke patient or the dominant hand for healthy volunteers. Videos of the hand will be made using the Darfish system which will allow analysis of the primary endpoint.
Two mobilizations will be performed for each participant, i.e. one for each type of medial or lateral grip. The order of mobilization will be determined by randomization.
- Conditions
- Muscle Spasticity, Stroke
- Being tested
- Passive extension mobilization of the hand and wrist joints
- Keywords
- Muscle Spasticity, Mobilization, Wrist and Hand Complex
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive extension mobilization of the hand and wrist jointsProcedure or surgery
The physiotherapist will proceed with the passive mobilization of the spastic hand of the stroke patient or the dominant hand for healthy volunteers.
Two mobilizations will be performed for each participant, i.e. one for each type of medial or lateral grip. The order of mobilization will be determined by randomization.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients with hand spasticity (n=20) | Other | Not described Receives: Procedure: Passive extension mobilization of the hand and wrist joints |
| Healthy volunteers (n=10) | Other | Not described Receives: Procedure: Passive extension mobilization of the hand and wrist joints |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude values
Amplitude values will be calculated with the Dartfish® system
Measured: 1 minute after intervention
Angular velocity values
Angular velocity values will be calculated with the Dartfish® system
Measured: 1 minute after intervention
Secondary outcomes (8)
Mean amplitude of the two groups
Measured: 1 minute after intervention
Mean angular velocity of the two groups
Measured: 1 minute after intervention
Mean amplitude after mobilization with thumb abduction
Measured: 1 minute after intervention
Mean angular velocity after mobilization with thumb abduction
Measured: 1 minute after intervention
Mean amplitude after mobilization of the fifth finger
Measured: 1 minute after intervention
Mean angular velocity after mobilization of the fifth finger
Measured: 1 minute after intervention
Pain experienced by stroke patients before mobilisation
Pain will be assessed by the Visual Analogue Scale (VAS)
Measured: 1 minute before intervention
Pain experienced by stroke patients after mobilisation
Pain will be assessed by the Visual Analogue Scale (VAS)
Measured: 1 minute after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start10 Mar 2020
- Primary completion18 Mar 2020
- Study completion18 Mar 2020
Why it stopped: recruitement issues related to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Winisdoerffer, Principal investigator, GHRMSA hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502927
- Sponsor's protocol ID
- GHR 1020
- Other IDs
- IDRCB 2019-A02953-54
- Acronym
- PHYSIOHAND
- Status last verified
- Jun 2021
- First submitted
- 3 Aug 2020
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurements of Displacement Amplitude and Angular Velocities During Passive Extension of the Wrist and Hand Complex in Stroke Patients
- ClinicalTrials.gov ID
- NCT04502927
- Acronym / sponsor ID
- PHYSIOHAND / GHR 1020
- Conditions
- Muscle Spasticity, Stroke
- Keywords
- Muscle Spasticity, Mobilization, Wrist and Hand Complex
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitement issues related to COVID-19
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 6 Aug 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.
The main objective of this monocentric prospective study is to evaluate the amplitudes and angular velocities of extension of the hand and wrist joints during passive mobilization by a physiotherapist in healthy subjects and stroke patients with spastic hands.
Secondary objectives:
- To compare amplitude and angular velocity values between the group of stroke patients and the group of healthy volunteers,
- To compare amplitude and angular velocity values according to the two types of mobilization (i,e, thumb or fifth finger),
- To assess pain due to mobilization in stroke patients.
Detailed description
Conduct of research:
The realization of the measures will take place at the GHRMSA rehabilitation department.
After receiving the written consent of the study participant, the physiotherapist will proceed with the passive mobilization of the spastic hand of the stroke patient or the dominant hand for healthy volunteers. Videos of the hand will be made using the Darfish system which will allow analysis of the primary endpoint.
Two mobilizations will be performed for each participant, i.e. one for each type of medial or lateral grip. The order of mobilization will be determined by randomization.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke patients with hand spasticity (n=20) | Other | Procedure: Passive extension mobilization of the hand and wrist joints |
| Healthy volunteers (n=10) | Other | Procedure: Passive extension mobilization of the hand and wrist joints |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old
- First stroke diagnosed less than 3 months ago
- Non-functional wrist defined by the Fugl-Meyer Assesment (FMA-EU) upper limb motor subscale with a score ≤45
- Wrist flexor spasticity defined by the Modified Tardieu Scale (MTS) with a rating ≥1
- Written informed consent
Key exclusion criteria (3 listed)
- None
- None
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 |
|---|---|---|
| Passive extension mobilization of the hand and wrist jointsThe physiotherapist will proceed with the passive mobilization of the spastic hand of the stroke patient or the dominant hand for healthy volunteers. Two mobilizations will be performed for each participant, i.e. one for each type of medial or lateral grip. The order of mobilization will be determined by randomization. | Procedure or surgery | Healthy volunteers (n=10), Stroke patients with hand spasticity (n=20) |
Primary outcome
Amplitude values
Time frame: 1 minute after intervention
Amplitude values will be calculated with the Dartfish® system
Angular velocity values
Time frame: 1 minute after intervention
Angular velocity values will be calculated with the Dartfish® system
8 secondary outcomes
Mean amplitude of the two groups
Time frame: 1 minute after intervention
Mean angular velocity of the two groups
Time frame: 1 minute after intervention
Mean amplitude after mobilization with thumb abduction
Time frame: 1 minute after intervention
Mean angular velocity after mobilization with thumb abduction
Time frame: 1 minute after intervention
Mean amplitude after mobilization of the fifth finger
Time frame: 1 minute after intervention
Mean angular velocity after mobilization of the fifth finger
Time frame: 1 minute after intervention
Pain experienced by stroke patients before mobilisation
Time frame: 1 minute before intervention
Pain experienced by stroke patients after mobilisation
Time frame: 1 minute after intervention
Results and safety
The study was stopped early (reason given: recruitement issues related to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Muscle Spasticity
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
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Dystonic Cerebral Palsy
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Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
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Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence
Spasticity, Stroke
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 Winisdoerffer principal investigator
GHRMSA hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive extension mobilization of the hand and wrist joints in people with Muscle Spasticity and Stroke, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace 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 7 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: stopped early, as of the sponsor's last update on 8 Jul 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: recruitement issues related to COVID-19). 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?
Amplitude values (time frame: 1 minute after intervention). The study lists 2 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 8 Jul 2021.