HemiplegiaERIAMSNCT02904148
Passive Mobilisation of Region of Shoulder Joints for Hemiplegic Patient
A study testing Shoulder mobilisation in people with Hemiplegia, run by Centre Hospitalier Universitaire de la Réunion.
Trial summary
Hemiplegia is a high prevalence pathology with 1 per 1000 habitants in France. One of these complications is shoulder pain which affects about 35 to 70% of cases. The medical care of this complication is critical because it affects the patient's quality of life and also hinders participation in rehabilitation sessions… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemiplegia
- What is being tested?
- Shoulder mobilisation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Sep 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized in Physical Medicine and Rehabilitation at Centre Hospitalier Universitaire Réunion (Site of Le Tampon)
- Having made a cerebrovascular accident between 30 and 3 days before inclusion
- with pain in the upper limb whose score with visual analogue scale is greater than or equal to 20 mm
- able to understand the question: "Do you have arm pain?"
Who cannot join
- with visual analogue scale score lower than 20 mm at the inclusion
- with aphasia of comprehension
- with medical contraindication for passive shoulder mobilisation (Shoulder fracture, dislocation,...)
- opposing to any mobilization
- with shoulder pathology previously known
- history of cerebrovascular accident prior 30 days before inclusion
About this study
Official title: Measurement of the Analgesic Efficacy of Shoulder Mobilization in Hemiplegic Patients
Hemiplegia is a high prevalence pathology with 1 per 1000 habitants in France. One of these complications is shoulder pain which affects about 35 to 70% of cases. The medical care of this complication is critical because it affects the patient's quality of life and also hinders participation in rehabilitation sessions slowing the recovery of independence in activities of daily living.
Literature confirmed the involvement of the scapula in the hemiplegic shoulder pain with his attitude pronounced lateral rotation. But no data to confirm that passive mobilization reduce shoulder pain.
Because no data available to permit us to determine the sample size we set-up this preliminary study to check if efficiency found in these preliminary data are consistent with an estimable real efficacy in a randomized trial feasible.
- Conditions
- Hemiplegia
- Being tested
- Shoulder mobilisation
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder mobilisationProcedure or surgery
early shoulder mobilisation
| Study group | Role | What they receive |
|---|---|---|
| Shoulder mobilisation | Experimental | The shoulder mobilisation is performed daily by a physiotherapist for 45 days. Receives: Procedure: Shoulder mobilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evaluation with visual analogic scale
Proportion of patients reducing by at least 20 mm their score on the visual analogic scale (VAS) from baseline Day 45
Measured: Change of pain evaluation between Day 0 and Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startJan 2020 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andre Muller, MD, Principal investigator, CHU de La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904148
- Sponsor's protocol ID
- 2015/CHU/09
- Acronym
- ERIAMS
- Status last verified
- Jul 2019
- First submitted
- 8 Sep 2016
- Last updated
- 26 Nov 2019
- 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 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Analgesic Efficacy of Shoulder Mobilization in Hemiplegic Patients
- ClinicalTrials.gov ID
- NCT02904148
- Acronym / sponsor ID
- ERIAMS / 2015/CHU/09
- Conditions
- Hemiplegia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 16 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.
Hemiplegia is a high prevalence pathology with 1 per 1000 habitants in France. One of these complications is shoulder pain which affects about 35 to 70% of cases. The medical care of this complication is critical because it affects the patient's quality of life and also hinders participation in rehabilitation sessions slowing the recovery of independence in activities of daily living.
Literature confirmed the involvement of the scapula in the hemiplegic shoulder pain with his attitude pronounced lateral rotation. But no data to confirm that passive mobilization reduce shoulder pain.
Because no data available to permit us to determine the sample size we set-up this preliminary study to check if efficiency found in these preliminary data are consistent with an estimable real efficacy in a randomized trial feasible.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shoulder mobilisation | Experimental | Procedure: Shoulder mobilisationThe shoulder mobilisation is performed daily by a physiotherapist for 45 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized in Physical Medicine and Rehabilitation at Centre Hospitalier Universitaire Réunion (Site of Le Tampon)
- Having made a cerebrovascular accident between 30 and 3 days before inclusion
- with pain in the upper limb whose score with visual analogue scale is greater than or equal to 20 mm
- able to understand the question: "Do you have arm pain?"
Key exclusion criteria (6 listed)
- with visual analogue scale score lower than 20 mm at the inclusion
- with aphasia of comprehension
- with medical contraindication for passive shoulder mobilisation (Shoulder fracture, dislocation,...)
- opposing to any mobilization
- with shoulder pathology previously known
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 |
|---|---|---|
| Shoulder mobilisationearly shoulder mobilisation | Procedure or surgery | Shoulder mobilisation |
Primary outcome
Pain evaluation with visual analogic scale
Time frame: Change of pain evaluation between Day 0 and Day 45
Proportion of patients reducing by at least 20 mm their score on the visual analogic scale (VAS) from baseline Day 45
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Andre Muller, MD principal investigator
CHU de La Réunion
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder mobilisation in people with Hemiplegia, run by Centre Hospitalier Universitaire de la Réunion.
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 4 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: withdrawn, as of the sponsor's last update on 26 Nov 2019. 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. 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 withdrawn before enrolling participants, so there are no results.
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?
Pain evaluation with visual analogic scale (time frame: Change of pain evaluation between Day 0 and Day 45). 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 26 Nov 2019.