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CompletedNCT03584035SMIEUpdated Aug 13, 2019

Sensorimotor Integration Exercises on Post-stroke Balance and Fall Efficacy

An interventional study of sensory motor integration exercises and conventional physiotherapy in Stroke, sponsored by Mahidol University. Completed at 2 sites in Myanmar. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-13.

Sponsored by Mahidol University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Stroke

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Keywords

  • sensory motor integration exercise
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's enrollment of 46 is close to the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • First episode of sub-acute stroke (from 1 to 26 weeks) referred from physicians
  • Both sexes
  • Age above 20
  • Good cognition ( Scale ≥24)
  • Moderate and moderately severe disability (Modified Rankin Scale- 3 and 4)
  • Impaired balance (BBS \<41)

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Sensory motor integration group

    Sensory-motor integration exercises with 3 progressive steps, 30 minutes per sessions, 3 sessions per week for 6 weeks.

    Behavioral: sensory motor integration exercises

  • Active comparator
    Conventional group

    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.

    Behavioral: conventional physiotherapy

Interventions

  • Behavioralsensory motor integration exercises

    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.

  • Behavioralconventional physiotherapy

    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.

06

What researchers measure

Primary outcomes

  1. Berg Balance Scale (BBS)

    14 items to measure static and dynamic balance

    Time frame: 6 weeks

Secondary outcomes

  1. Functional Reach Test

    To assess the stability by measuring the maximum distance while standing in a fixed position

    Time frame: 6 weeks

  2. 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.

    Time frame: 6 weeks

07

Study locations

2 sites
  • National Rehabilitation Hospital
    Yangon, 11062, Myanmar
  • Physical Medicine and Rehabilitation Department, Yangon General Hospital
    Yangon, Myanmar
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2018 to primary completion in May 2019, 12 months.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 12 months is below that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2018
First posted
Jul 12, 2018
StartActual
May 2, 2018
Primary completionActual
May 30, 2019
CompletionActual
Jul 30, 2019
Last update
Aug 13, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03584035
Lead sponsor
Mahidol University
Collaborators
University of Medical Technology, Yangon
Responsible party
Thin Thin Moe (Ph D, Mahidol University) — Principal investigator
First posted
Jul 12, 2018
Start date
May 2, 2018
Primary completion
May 30, 2019
Completion
Jul 30, 2019
Last update
Aug 13, 2019

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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