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Post StrokeNCT06500611

Combined Effects Of Sensory Integration And Vestibular Exercises On Post-Stroke Patients

A study testing Sensory Integration and Vestibular Exercise with Routine Physical Therapy and Vestibular Exercise with Routine Physical Therapy in people with Post Stroke, run by Riphah International University at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of this study is to determine the combined effects of sensory integration and vestibular exercise on dizziness, fall risk and quality of life. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Post Stroke
What is being tested?
Sensory Integration and Vestibular Exercise with Routine Physical Therapy and Vestibular Exercise with Routine Physical Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 sitePakistan
Study dates
10 Jul 2024to 30 Mar 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Both male and female
  • Age between 40years-65years
  • those who have been diagnosed with vestibular disorders
  • An ability to stand for for 5 minutes without aid measured by 5 times sit to stand test.

Who cannot join

  • Have bilateral or unstable vestibular loss
  • Any neurological condition is present
  • Active BPPV is present
  • Any acute orthopaedic condition is present
  • Peripheral neuropathy is present
  • Visual impairment not corrected with glasses.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pakistan1 site, 1 recruiting
  • Riphah Rehab Center

    Lahore, Punjab Province, 54660

    Aruba Saeed, 03344399403, aruba.saeed@riphah.edu.pk

    Recruiting

Other trials in Pakistan

About this study

Official title: Combined Effects Of Sensory Integration And Vestibular Exercises On Dizziness, Fall Risk And Quality Of Life In Post-Stroke Patients

The aim of this study is to determine the combined effects of sensory integration and vestibular exercise on dizziness, fall risk and quality of life.

Read the detailed description

This randomized controlled trial will be conducted at Mansoorah Teaching Hospital in 7 months after the approval of the synopsis. 38 participants with stroke will be included as per the sample size calculation through the convenience sampling technique. Participants who meet inclusion criteria will be randomly allocated using an online randomization tool into two groups Group A will receive Combine Sensory integration exercise and vestibular exercise with routine physical therapy for 40 minutes and Group B will receive Vestibular exercise with routine physical therapy for 40 minutes. Each group will receive a treatment session of 3 times in week for 6 weeks. The data will be analyzed using SPSS version 24.

Conditions
Post Stroke
Being tested
Sensory Integration and Vestibular Exercise with Routine Physical Therapy, Vestibular Exercise with Routine Physical Therapy
Keywords
sensory integration,, stroke, vestibular rehabilitation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sensory Integration and Vestibular Exercise with Routine Physical TherapyOther

    1. Stand with feet hip-width apart 5 rep
    2. Sit in chair without backrest 5 rep

    1.Stand with feet hip -width apart 5 rep

    2.Sit to stand sit on chair without backrest and perform sit to stand repeatedly 5 rep

    1.Tandem Walk one foot directly in front of the other.2 sets 5 steps forward and backward

    2.Patientwalk forward cross an obstacle, continue walk. Walk Lateral Walk Backward 2 sets

    1. Stand and slowly move head side to side and up down 10 repetition
    2. Fix gaze and move head side to side or up and down 10 repetitions
    3. Stand on one leg for 10 seconds hold on. Repeat 5 times on each leg.
    4. Stand and rotate body to right and left 10 rotations
    5. Walk on straight line , zigzag pattern, walk while looking your shoulder 5 rep
    6. Sit and swing your legs back and forth 5rep
    7. Play catch in standing. 2 sets 5-8 catches.

    Static stretching 30 sec hold 5 times

  • Vestibular Exercise with Routine Physical TherapyOther

    Vestibular exercise

    1. Stand with feet hip -width apart and slowly move head side to side and up down.10 repetitions for each direction.

    2 .Fix your gaze on object while moving your head side to side or up and down. 10 repetitions for each movement.

    1.Patient will stand on one leg for 10 second. Hold onto a stable support if needed. 5 times on each leg.

    1. Stand with feet hip-width apart and rotate body to the right and left. 10 rotations in each direction.
    2. Walk on a straight line or in a zigzag pattern or walk while looking over your shoulder. (5 rep)
    3. Sit on a stable chair and swing your legs back and forth, similar to a pendulum. (5rep)
    4. Catch and Throw play catch with a partner while standing. 2 sets of 5-8 catches.

    Routine Physical Therapu Static stretching exercises for 30 sec hold with 30 sec rest. 5 times for each muscle group

Study groups in NCT06500611
Study groupRoleWhat they receive
GROUP A (Sensory Integration and Vestibular Exercise with Routine Physical Therapy)ExperimentalSensory Integration Exercise: Week 1-2 1. Eyes Open Standing for 5 minutes. 2. Sitting position for 5 minutes. Week 3-4 1. Eyes Closed Standing for 5 minutes. 2. Sit to stand for 5 minutes. Week 5-6 1. Tandem Walk for 4 minutes. 2. Walk Obstacle Course for 4 minutes. Vestibular Exercise Week 1-2 1. Head Movements for 5 minutes 2. Gaze Stabilization for 5 minutes. Week 3-4 1. Single Leg Stance for 5 minutes. 2. Rotation Exercises for 5 minutes. Week 5-6 1. Walking Patterns for 4 minutes. 2. Pendulum Exercise for 4 minutes. 3. Catch and Throw for 4 minutes. Routine Physical Therapy for 20 minutes.
Receives: Other: Sensory Integration and Vestibular Exercise with Routine Physical Therapy
GROUP B (Vestibular Exercise with Routine Physical Therapy)ExperimentalVestibular Exercise Week 1-2 1. Head Movements for 10 minutes 2. Gaze Stabilization for 10 minutes. Week 3-4 1. Single Leg Stance for 10 minutes. 2. Rotation Exercises for 10 minutes. Week 5-6 1. Walking Patterns for 5 minutes. 2. Pendulum Exercise for 5 minutes. 3. Catch and Throw for 10 minutes. Routine Physical Therapy for 20 minutes.
Receives: Other: Vestibular Exercise with Routine Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined Effects Of Sensory Integration And Vestibular Exercises On Post-Stroke Patients

    DHI assesses Dizziness Consists 25 items three answers yes sometimes no. Highest disability 100 ,lowest one be 0.The SS-QOL, disease-specific consist 49 items 12 domains, social role (five questions), mobility (six questions), energy (three questions), language (five questions), self-care (five questions), mood (five questions), personality (three questions), thinking (three questions), upper extremity function (five questions), family role (three questions), vision (three questions),work/productivity (three questions). Each item ranked five-point level one means completely agreed while level five means completely disagree. Total score ranges from 49 to 245.Time up and go test Duration of ≥13.5 s associate increased fall risk with vestibular dysfunction. STRATIFY tool comprises five items risk factors past history falling, patient agitation, visual impairment, incontinence, transfer and mobility score range from 0 to 5 points and risk of falling is a score ≥ 2 points.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2024
  2. Study start10 Jul 2024
  3. Primary completion30 Mar 2025 (estimated)
  4. Study completion30 Mar 2025 (estimated)

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06500611
Sponsor's protocol ID
REC/RCR & AHS/23/0271
Status last verified
Apr 2025
First submitted
8 Jul 2024
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • He A, Wang Z, Wu X, Sun W, Yang K, Feng W, Wang Y, Song H. Incidence of post-stroke cognitive impairment in patients with first-ever ischemic stroke: a multicenter cross-sectional study in China. Lancet Reg Health West Pac. 2023 Jan 14;33:100687. doi: 10.1016/j.lanwpc.2023.100687. eCollection 2023 Apr.

    PubMed 37181529
  • Harjpal P, Qureshi MI, Kovela RK, Jain M. Efficacy of Bilateral Lower-Limb Training Over Unilateral Lower-Limb Training To Reeducate Balance and Walking in Post-Stroke Survivors: A Randomized Clinical Trial. Cureus. 2022 Oct 27;14(10):e30748. doi: 10.7759/cureus.30748. eCollection 2022 Oct.

    PubMed 36447690
  • Einstad MS, Saltvedt I, Lydersen S, Ursin MH, Munthe-Kaas R, Ihle-Hansen H, Knapskog AB, Askim T, Beyer MK, Naess H, Seljeseth YM, Ellekjaer H, Thingstad P. Associations between post-stroke motor and cognitive function: a cross-sectional study. BMC Geriatr. 2021 Feb 5;21(1):103. doi: 10.1186/s12877-021-02055-7.

    PubMed 33546620
  • Zhou Z, Lu J, Liu WW, Manaenko A, Hou X, Mei Q, Huang JL, Tang J, Zhang JH, Yao H, Hu Q. Advances in stroke pharmacology. Pharmacol Ther. 2018 Nov;191:23-42. doi: 10.1016/j.pharmthera.2018.05.012. Epub 2018 May 25.

    PubMed 29807056
  • Rodriguez-Fernandez A, Lobo-Prat J, Font-Llagunes JM. Systematic review on wearable lower-limb exoskeletons for gait training in neuromuscular impairments. J Neuroeng Rehabil. 2021 Feb 1;18(1):22. doi: 10.1186/s12984-021-00815-5.

    PubMed 33526065
  • Li S, Francisco GE, Zhou P. Post-stroke Hemiplegic Gait: New Perspective and Insights. Front Physiol. 2018 Aug 2;9:1021. doi: 10.3389/fphys.2018.01021. eCollection 2018.

    PubMed 30127749
  • Rodgers H, Bosomworth H, Krebs HI, van Wijck F, Howel D, Wilson N, Finch T, Alvarado N, Ternent L, Fernandez-Garcia C, Aird L, Andole S, Cohen DL, Dawson J, Ford GA, Francis R, Hogg S, Hughes N, Price CI, Turner DL, Vale L, Wilkes S, Shaw L. Robot-assisted training compared with an enhanced upper limb therapy programme and with usual care for upper limb functional limitation after stroke: the RATULS three-group RCT. Health Technol Assess. 2020 Oct;24(54):1-232. doi: 10.3310/hta24540.

    PubMed 33140719
  • Brown KE, Neva JL, Feldman SJ, Staines WR, Boyd LA. Sensorimotor integration in chronic stroke: Baseline differences and response to sensory training. Restor Neurol Neurosci. 2018;36(2):245-259. doi: 10.3233/RNN-170790.

    PubMed 29526859
  • Krishnan K, Bassilious K, Eriksen E, Bath PM, Sprigg N, Braekken SK, Ihle-Hansen H, Horn MA, Sandset EC. Posterior circulation stroke diagnosis using HINTS in patients presenting with acute vestibular syndrome: A systematic review. Eur Stroke J. 2019 Sep;4(3):233-239. doi: 10.1177/2396987319843701. Epub 2019 Apr 10.

    PubMed 31984230
  • Regauer V, Seckler E, Muller M, Bauer P. Physical therapy interventions for older people with vertigo, dizziness and balance disorders addressing mobility and participation: a systematic review. BMC Geriatr. 2020 Nov 23;20(1):494. doi: 10.1186/s12877-020-01899-9.

    PubMed 33228601
  • Lubetzky AV, Kelly J, Wang Z, Gospodarek M, Fu G, Sutera J, Hujsak BD. Contextual sensory integration training via head mounted display for individuals with vestibular disorders: a feasibility study. Disabil Rehabil Assist Technol. 2022 Jan;17(1):74-84. doi: 10.1080/17483107.2020.1765419. Epub 2020 May 18.

    PubMed 32421374
  • Ekvall Hansson E, Pessah-Rasmussen H, Bring A, Vahlberg B, Persson L. Vestibular rehabilitation for persons with stroke and concomitant dizziness-a pilot study. Pilot Feasibility Stud. 2020 Sep 30;6:146. doi: 10.1186/s40814-020-00690-2. eCollection 2020.

    PubMed 33005434
  • Xie G, Wang T, Jiang B, Su Y, Tang X, Guo Y, Liao J. Effects of hydrokinesitherapy on balance and walking ability in stroke survivors: a systematic review and meta-analysis of randomized controlled studies. Eur Rev Aging Phys Act. 2019 Nov 13;16:21. doi: 10.1186/s11556-019-0227-0. eCollection 2019.

    PubMed 31754406
  • Meng L, Liang Q, Yuan J, Li S, Ge Y, Yang J, Tsang RCC, Wei Q. Vestibular rehabilitation therapy on balance and gait in patients after stroke: a systematic review and meta-analysis. BMC Med. 2023 Aug 25;21(1):322. doi: 10.1186/s12916-023-03029-9.

    PubMed 37626339
  • Lubetzky AV, Harel D, Krishnamoorthy S, Fu G, Morris B, Medlin A, Wang Z, Perlin K, Roginska A, Cosetti M, Kelly J. Decrease in head sway as a measure of sensory integration following vestibular rehabilitation: A randomized controlled trial. J Vestib Res. 2023;33(3):213-226. doi: 10.3233/VES-220107.

    PubMed 36911951

Questions about this trial

What is this clinical trial studying?

A study testing Sensory Integration and Vestibular Exercise with Routine Physical Therapy and Vestibular Exercise with Routine Physical Therapy in people with Post Stroke, run by Riphah International University at 1 site in Pakistan.

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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. 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 Pakistan. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Saifa Zia (03454189876, saifazia@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined Effects Of Sensory Integration And Vestibular Exercises On Post-Stroke Patients (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06500611, which also lists 28 linked publications.

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 9 Apr 2025.

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