StrokeSMIENCT03584035
Sensorimotor Integration Exercises on Post-stroke Balance and Fall Efficacy
A study testing sensory motor integration exercises and conventional physiotherapy in people with Stroke, run by Mahidol University at 2 sites in Burma.
Trial summary
To study the effect of sensorimotor integration exercises on balance and fall efficacy in sub-acute stroke by performing 18 balance training exercises with three progressive steps. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- sensory motor integration exercises and conventional physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesBurma
- Study dates
- 2 May 2018to 30 Jul 2019
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First episode of sub-acute stroke (from 1 to 26 weeks) referred from physicians
- Both sexes
- Age above 20
- Good cognition (Mini Mental State Examination Scale ≥24)
- Moderate and moderately severe disability (Modified Rankin Scale- 3 and 4)
- Impaired balance (BBS <41)
Who cannot join
- Recurrent stroke
- Associated with other neurological conditions (such as Parkinson's disease, Epilepsy, meningitis)
- Deficits of somatic sensation involving the paretic limb (Fugl-Meyer Assessment - sesation< 1)
- Lower extremity weight bearing pain (Fugl-Meyer Assessment- pain <1)
- Low back pain (VAS ≥ 3)
- Severe visual deficits which cannot be corrected by lens or glasses
- Symptomatic vestibular disorders (Paroxysmal postural vertigo)
- Associated serious cardiac disorder
Trial locations and contacts
2 sites in 1 country.
Burma2 sites
National Rehabilitation Hospital
Yangon, 11062
Physical Medicine and Rehabilitation Department, Yangon General Hospital
Yangon
About this study
Official title: Effects of Sensorimotor Integration Exercises on Balance and Fall Efficacy in Sub-acute Stroke
To study the effect of sensorimotor integration exercises on balance and fall efficacy in sub-acute stroke by performing 18 balance training exercises with three progressive steps.
Read the detailed description
Balance impairment after stroke is significantly correlated with fall risk. To improve balance and reduce fall efficacy, the participants in the study group will be trained by six weeks three progressive steps of sensorimotor integration exercises. Each exercise step will take 30 minutes of a practice session, three sessions per week. Conventional physiotherapy (passive and active exercises and lower extremities strengthening exercises) will be given to the control group. The changes in balance performance and fall efficacy will be measured and compared within and between groups.
- Conditions
- Stroke
- Being tested
- sensory motor integration exercises, conventional physiotherapy
- Keywords
- sensory motor integration exercise
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensory motor integration exercisesBehavioural
Sensorimotor integration exercises will be given in study group. The exercises will be performed in standing, sitting and walking. Exercises will be progressively increased from eye open to closed , floor to mat and head turns to right \& left under the supervision of physiotherapist. Sensorimotor integration exercises will take 45 minutes in each session.
conventional physiotherapyBehavioural
Conventional physiotherapy will take 30 minutes in each session, taking three sessions per weeks for six weeks. The exercises include simple lower extremity exercise and ambulatory training such as sit to stand, stepping, lateral and backward walking, and tandom walking etc.
| Study group | Role | What they receive |
|---|---|---|
| Sensory motor integration group | Experimental | Sensory-motor integration exercises with 3 progressive steps, 30 minutes per sessions, 3 sessions per week for 6 weeks. Receives: Behavioral: sensory motor integration exercises |
| Conventional group | Active comparator | Conventional exercises include simple passive and active exercises and lower extremities strengthening exercises for balance and ambulation. The exercise session will last 30 minutes for 3 sessions per week. The total intervention period is 6 weeks. Receives: Behavioral: conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
14 items to measure static and dynamic balance
Measured: 6 weeks
Secondary outcomes (2)
Functional Reach Test
To assess the stability by measuring the maximum distance while standing in a fixed position
Measured: 6 weeks
Fall Efficacy Scale
Short, easy questionnaire that provides information about how much fear of fall, which is comprised of 16-items concerning confidence in maintaing balance during activities.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start2 May 2018
- Primary completion30 May 2019
- Study completion30 Jul 2019
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Medical Technology, Yangon
- Responsible party
- Principal investigator, Thin Thin Moe, Mahidol University
- Investigators
- May Phyu Phyu Maung, B.Med.Tech, Principal investigator, University of Medical Technology, YangonThin Thin Moe, Ph.D, Principal investigator, Mahidol UniversityMyo Thuzar Khin, Ph.D, Study chair, University of Medical Technology, Yangon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584035
- Sponsor's protocol ID
- 3-2018
- Acronym
- SMIE
- Status last verified
- Aug 2019
- First submitted
- 29 Jun 2018
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sensorimotor Integration Exercises on Balance and Fall Efficacy in Sub-acute Stroke
- ClinicalTrials.gov ID
- NCT03584035
- Acronym / sponsor ID
- SMIE / 3-2018
- Conditions
- Stroke
- Keywords
- sensory motor integration exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- University of Medical Technology, Yangon
- Study start
- 2 May 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 12 Jul 2018 (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.
To study the effect of sensorimotor integration exercises on balance and fall efficacy in sub-acute stroke by performing 18 balance training exercises with three progressive steps.
Detailed description
Balance impairment after stroke is significantly correlated with fall risk. To improve balance and reduce fall efficacy, the participants in the study group will be trained by six weeks three progressive steps of sensorimotor integration exercises. Each exercise step will take 30 minutes of a practice session, three sessions per week. Conventional physiotherapy (passive and active exercises and lower extremities strengthening exercises) will be given to the control group. The changes in balance performance and fall efficacy will be measured and compared within and between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Sensory motor integration group | Experimental | Behavioral: sensory motor integration exercisesSensory-motor integration exercises with 3 progressive steps, 30 minutes per sessions, 3 sessions per week for 6 weeks. |
| Conventional group | Active comparator | Behavioral: conventional physiotherapyConventional exercises include simple passive and active exercises and lower extremities strengthening exercises for balance and ambulation. The exercise session will last 30 minutes for 3 sessions per week. The total intervention period is 6 weeks. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First episode of sub-acute stroke (from 1 to 26 weeks) referred from physicians
- Both sexes
- Age above 20
- Good cognition (Mini Mental State Examination Scale ≥24)
- Moderate and moderately severe disability (Modified Rankin Scale- 3 and 4)
Key exclusion criteria (8 listed)
- Recurrent stroke
- Associated with other neurological conditions (such as Parkinson's disease, Epilepsy, meningitis)
- Deficits of somatic sensation involving the paretic limb (Fugl-Meyer Assessment - sesation< 1)
- Lower extremity weight bearing pain (Fugl-Meyer Assessment- pain <1)
- Low back pain (VAS ≥ 3)
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 |
|---|---|---|
| sensory motor integration exercisesSensorimotor integration exercises will be given in study group. The exercises will be performed in standing, sitting and walking. Exercises will be progressively increased from eye open to closed , floor to mat and head turns to right \& left under the supervision of physiotherapist. Sensorimotor integration exercises will take 45 minutes in each session. | Behavioural | Sensory motor integration group |
| conventional physiotherapyConventional physiotherapy will take 30 minutes in each session, taking three sessions per weeks for six weeks. The exercises include simple lower extremity exercise and ambulatory training such as sit to stand, stepping, lateral and backward walking, and tandom walking etc. | Behavioural | Conventional group |
Primary outcome
Berg Balance Scale (BBS)
Time frame: 6 weeks
14 items to measure static and dynamic balance
2 secondary outcomes
Functional Reach Test
Time frame: 6 weeks
Fall Efficacy Scale
Time frame: 6 weeks
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 13 Aug 2019.
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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.
May Phyu Phyu Maung, B.Med.Tech principal investigator
University of Medical Technology, Yangon
Thin Thin Moe, Ph.D principal investigator
Mahidol University
Myo Thuzar Khin, Ph.D study chair
University of Medical Technology, Yangon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensory motor integration exercises and conventional physiotherapy in people with Stroke, run by Mahidol University at 2 sites in Burma.
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 6 inclusion and 8 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 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burma. 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?
Berg Balance Scale (BBS) (time frame: 6 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 13 Aug 2019.