StrokeNCT03094377
Effect of Multisensory Stimulation on Upper Extremity Motor Recovery in Stroke Patient: a Preliminary Testing
A study testing Multisensory therapy and Conventional training in people with Stroke, run by Tung Wah College at 1 site in Hong Kong.
Trial summary
Despite the advances in stroke rehabilitation, post-stroke upper extremity impairment is still a major challenge. Increasing evidence can be found supporting stimulation of the afferent receptor enhances neuroplasticity in the brain. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Multisensory therapy and Conventional training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2015to 31 Dec 2015
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-time ischemic or hemorrhagic stroke;
- Stroke onset > 4 weeks and < 6 months
- Single lesion
- Upper extremity motor deficit
- No severe cognitive impairment and able to follow verbal instructions.
Who cannot join
- Skin conditions/ injuries over the stimulation application areas
- Contraindication for cold or vibration application
- Speech disorder or global aphasia
- Musculoskeletal or cardiac disorders
- Other neurological conditions
- History of diabetes or sensory impairment attributable to peripheral vascular disease or neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
Despite the advances in stroke rehabilitation, post-stroke upper extremity impairment is still a major challenge. Increasing evidence can be found supporting stimulation of the afferent receptor enhances neuroplasticity in the brain. Studies have suggested multisensory stimulation could promote motor learning by re-establishing the disrupted sensorimotor loop due to stroke and enhance neuroplasticity.
The objective of the study was to examine the effect of multisensory stimulation on upper-extremity motor recovery and self-care function in stroke patients.
Read the detailed description
Stroke patients referred to occupational therapy division of geriatric day hospital will be recruited and randomly assigned to a multisensory therapy group or a conventional training group. The Multisensory therapy group received 12 weeks (two sessions/ week; 90 minutes/session) training. Each session began with 15 minutes of sensory stimulation (cold and vibration), 45 minutes of motor training and 30 minutes of self-care training. The conventional training group included 12 weeks (two sessions/ week; 90 minutes/session) training. Each session included 60 minutes of upper extremity motor practice and 30 minutes of self-care training.
Outcome measures included: Brunnstrom's stage, Fugl-Meyer Assessment Scale and Functional Test for the Hemiplegic Upper Extremity were used for upper limb motor control and function; and Manual muscle testing was used for muscle strength. The modified Barthel Index was used for self-care performance
- Conditions
- Stroke
- Being tested
- Multisensory therapy, Conventional training
- Keywords
- Multisensory stimulation; motor recovery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory therapyOther
Sensory stimulation, motor training and ADL training
Conventional trainingOther
Motor training and ADL training
| Study group | Role | What they receive |
|---|---|---|
| Multisensory therapy group | Experimental | The Multisensory therapy (MT) group received a 12-weeks (two sessions/ week; 90 minutes/session) training conducted by an occupational therapist. Each session began with 15 minutes of sensory stimulation (cold and vibration), 45 minutes of motor training and 30 minutes of self-care training. Receives: Other: Multisensory therapy |
| Conventional training group | Active comparator | The conventional training (CT) group included 12 weeks (two sessions/ week; 90 minutes/session) training conducted by an occupational therapist. Each session included 60 minutes of upper extremity motor practice (same as in MT group) and 30 minutes of self-care training (same as in MT group). Receives: Other: Conventional training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Fugl-Meyer Assessment of Motor Recovery at 3 months
The Fugl-Meyer Assessment was used to assess the progress in synergistic and voluntary movement at baseline and post intervention.
Measured: Baseline and post intervention at week 12
Change from baseline Functional Test for the Hemiplegic Upper Extremity at 3 months
The Functional Test for the Hemiplegic Upper Extremity was used to evaluate the recovery of the hemiplegic upper extremity functions at baseline and post intervention.
Measured: Baseline and post intervention at week 12
Secondary outcomes (2)
Change from baseline Modified Barthel Index at 3 months
The Modified Barthel Index was used to measure functional performance in basic activities of daily living at baseline and post intervention.
Measured: Baseline and post intervention at week 12
Change from baseline Manual Muscle testing at 3 months
Manual muscle testing (MMT) was used for the evaluation of the motor recovery and strength of upper extremity muscle groups at baseline and post intervention.
Measured: Baseline and post intervention at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start1 Mar 2015
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This was a quasi-randomized-controlled pilot. Participants were randomly allocated by admission sequence to a multisensory therapy group or a conventional training group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tung Wah College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ray KF Li, Tung Wah College
- Investigators
- Ray Li, Master, Principal investigator, Occupational Therapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094377
- Sponsor's protocol ID
- U1111-1193-6547
- Status last verified
- Mar 2017
- First submitted
- 13 Mar 2017
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share all the available data as requested
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multisensory Stimulation on Upper Extremity Motor Recovery in Stroke Patient: a Preliminary Testing
- ClinicalTrials.gov ID
- NCT03094377
- Acronym / sponsor ID
- U1111-1193-6547
- Conditions
- Stroke
- Keywords
- Multisensory stimulation; motor recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tung Wah CollegeUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 29 Mar 2017 (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.
Despite the advances in stroke rehabilitation, post-stroke upper extremity impairment is still a major challenge. Increasing evidence can be found supporting stimulation of the afferent receptor enhances neuroplasticity in the brain. Studies have suggested multisensory stimulation could promote motor learning by re-establishing the disrupted sensorimotor loop due to stroke and enhance neuroplasticity.
The objective of the study was to examine the effect of multisensory stimulation on upper-extremity motor recovery and self-care function in stroke patients.
Detailed description
Stroke patients referred to occupational therapy division of geriatric day hospital will be recruited and randomly assigned to a multisensory therapy group or a conventional training group. The Multisensory therapy group received 12 weeks (two sessions/ week; 90 minutes/session) training. Each session began with 15 minutes of sensory stimulation (cold and vibration), 45 minutes of motor training and 30 minutes of self-care training. The conventional training group included 12 weeks (two sessions/ week; 90 minutes/session) training. Each session included 60 minutes of upper extremity motor practice and 30 minutes of self-care training.
Outcome measures included: Brunnstrom's stage, Fugl-Meyer Assessment Scale and Functional Test for the Hemiplegic Upper Extremity were used for upper limb motor control and function; and Manual muscle testing was used for muscle strength. The modified Barthel Index was used for self-care performance
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a quasi-randomized-controlled pilot. Participants were randomly allocated by admission sequence to a multisensory therapy group or a conventional training group
| Arm | Type | Receives |
|---|---|---|
| Multisensory therapy group | Experimental | Other: Multisensory therapyThe Multisensory therapy (MT) group received a 12-weeks (two sessions/ week; 90 minutes/session) training conducted by an occupational therapist. Each session began with 15 minutes of sensory stimulation (cold and vibration), 45 minutes of motor training and 30 minutes of self-care training. |
| Conventional training group | Active comparator | Other: Conventional trainingThe conventional training (CT) group included 12 weeks (two sessions/ week; 90 minutes/session) training conducted by an occupational therapist. Each session included 60 minutes of upper extremity motor practice (same as in MT group) and 30 minutes of self-care training (same as in MT group). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First-time ischemic or hemorrhagic stroke;
- Stroke onset > 4 weeks and < 6 months
- Single lesion
- Upper extremity motor deficit
- No severe cognitive impairment and able to follow verbal instructions.
Key exclusion criteria (6 listed)
- Skin conditions/ injuries over the stimulation application areas
- Contraindication for cold or vibration application
- Speech disorder or global aphasia
- Musculoskeletal or cardiac disorders
- Other neurological conditions
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 |
|---|---|---|
| Multisensory therapySensory stimulation, motor training and ADL training | Other | Multisensory therapy group |
| Conventional trainingMotor training and ADL training | Other | Conventional training group |
Primary outcome
Change from baseline Fugl-Meyer Assessment of Motor Recovery at 3 months
Time frame: Baseline and post intervention at week 12
The Fugl-Meyer Assessment was used to assess the progress in synergistic and voluntary movement at baseline and post intervention.
Change from baseline Functional Test for the Hemiplegic Upper Extremity at 3 months
Time frame: Baseline and post intervention at week 12
The Functional Test for the Hemiplegic Upper Extremity was used to evaluate the recovery of the hemiplegic upper extremity functions at baseline and post intervention.
2 secondary outcomes
Change from baseline Modified Barthel Index at 3 months
Time frame: Baseline and post intervention at week 12
Change from baseline Manual Muscle testing at 3 months
Time frame: Baseline and post intervention at week 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 29 Mar 2017.
- Individual participant dataSharing planned: Yes. Share all the available data as requested
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Ray Li, Master principal investigator
Occupational Therapist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multisensory therapy and Conventional training in people with Stroke, run by Tung Wah College at 1 site in Hong Kong.
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 29 Mar 2017. 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 Hong Kong. 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?
Change from baseline Fugl-Meyer Assessment of Motor Recovery at 3 months (time frame: Baseline and post intervention at week 12). 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 29 Mar 2017.