NCT06500611

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

July 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

July 8, 2024

Last Update Submit

April 7, 2025

Conditions

Keywords

sensory integration,strokevestibular rehabilitation

Outcome Measures

Primary Outcomes (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.

    6 weeks

Study Arms (2)

GROUP A (Sensory Integration and Vestibular Exercise with Routine Physical Therapy)

EXPERIMENTAL

Sensory 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.

Other: Sensory Integration and Vestibular Exercise with Routine Physical Therapy

GROUP B (Vestibular Exercise with Routine Physical Therapy)

EXPERIMENTAL

Vestibular 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.

Other: Vestibular Exercise with Routine Physical Therapy

Interventions

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 1\. Stand on one leg for 10 seconds hold on. Repeat 5 times on each leg. 2\. Stand and rotate body to right and left 10 rotations 1. Walk on straight line , zigzag pattern, walk while looking your shoulder 5 rep 2. Sit and swing your legs back and forth 5rep 3. Play catch in standing. 2 sets 5-8 catches. Static stretching 30 sec hold 5 times

GROUP A (Sensory Integration and Vestibular Exercise with Routine Physical Therapy)

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

GROUP B (Vestibular Exercise with Routine Physical Therapy)

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehab Center

Lahore, Punjab Province, 54660, Pakistan

RECRUITING

Related Publications (28)

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    PMID: 33140719BACKGROUND
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    PMID: 29526859BACKGROUND
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    PMID: 31984230BACKGROUND
  • 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.

    PMID: 33228601BACKGROUND
  • 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.

    PMID: 32421374BACKGROUND
  • 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.

    PMID: 33005434BACKGROUND
  • 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.

    PMID: 31754406BACKGROUND
  • 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.

    PMID: 37626339BACKGROUND
  • 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.

    PMID: 36911951BACKGROUND
  • Ghaffari A, Asadi B, Zareian A, Akbarfahimi M, Raissi GR, Fathali Lavasani F. The Effects of Vestibular Rehabilitation on Poststroke Fatigue: A Randomized Controlled Trial Study. Stroke Res Treat. 2022 Aug 31;2022:3155437. doi: 10.1155/2022/3155437. eCollection 2022.

    PMID: 36090743BACKGROUND
  • Tramontano M, Russo V, Spitoni GF, Ciancarelli I, Paolucci S, Manzari L, Morone G. Efficacy of Vestibular Rehabilitation in Patients With Neurologic Disorders: A Systematic Review. Arch Phys Med Rehabil. 2021 Jul;102(7):1379-1389. doi: 10.1016/j.apmr.2020.11.017. Epub 2020 Dec 28.

    PMID: 33383031BACKGROUND
  • Mitsutake T, Imura T, Tanaka R. The Effects of Vestibular Rehabilitation on Gait Performance in Patients with Stroke: A Systematic Review of Randomized Controlled Trials. J Stroke Cerebrovasc Dis. 2020 Nov;29(11):105214. doi: 10.1016/j.jstrokecerebrovasdis.2020.105214. Epub 2020 Aug 8.

    PMID: 33066892BACKGROUND
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    PMID: 31708735BACKGROUND
  • Adomaviciene A, Daunoraviciene K, Kubilius R, Varzaityte L, Raistenskis J. Influence of New Technologies on Post-Stroke Rehabilitation: A Comparison of Armeo Spring to the Kinect System. Medicina (Kaunas). 2019 Apr 9;55(4):98. doi: 10.3390/medicina55040098.

    PMID: 30970655BACKGROUND
  • Kelly J, Harel D, Krishnamoorthy S, Fu G, Morris B, Medlin A, Mischinati S, Wang Z, Sutera J, Perlin K, Cosetti M, Lubetzky AV. Contextual sensory integration training vs. traditional vestibular rehabilitation: a pilot randomized controlled trial. J Neuroeng Rehabil. 2023 Aug 12;20(1):104. doi: 10.1186/s12984-023-01224-6.

    PMID: 37568216BACKGROUND
  • Jang SH, Lee JH. Impact of sensory integration training on balance among stroke patients: sensory integration training on balance among stroke patients. Open Med (Wars). 2016 Aug 13;11(1):330-335. doi: 10.1515/med-2016-0061. eCollection 2016.

    PMID: 28352817BACKGROUND
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    PMID: 20025754BACKGROUND
  • Mahmoodi M, Safari A, Vossoughi M, Golbon-Haghighi F, Kamali-Sarvestani M, Ghaem H, Borhani-Haghighi A. Stroke specific quality of life questionnaire: Test of reliability and validity of the Persian version. Iran J Neurol. 2015 Apr 4;14(2):94-100.

    PMID: 26056554BACKGROUND
  • Alghadir AH, Al-Eisa ES, Anwer S, Sarkar B. Reliability, validity, and responsiveness of three scales for measuring balance in patients with chronic stroke. BMC Neurol. 2018 Sep 13;18(1):141. doi: 10.1186/s12883-018-1146-9.

    PMID: 30213258BACKGROUND
  • Aranda-Gallardo M, Enriquez de Luna-Rodriguez M, Vazquez-Blanco MJ, Canca-Sanchez JC, Moya-Suarez AB, Morales-Asencio JM. Diagnostic validity of the STRATIFY and Downton instruments for evaluating the risk of falls by hospitalised acute-care patients: a multicentre longitudinal study. BMC Health Serv Res. 2017 Apr 17;17(1):277. doi: 10.1186/s12913-017-2214-3.

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  • Choi JU, Kang SH. The effects of patient-centered task-oriented training on balance activities of daily living and self-efficacy following stroke. J Phys Ther Sci. 2015 Sep;27(9):2985-8. doi: 10.1589/jpts.27.2985. Epub 2015 Sep 30.

    PMID: 26504340BACKGROUND
  • Ricci NA, Aratani MC, Caovilla HH, Gananca FF. Effects of Vestibular Rehabilitation on Balance Control in Older People with Chronic Dizziness: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2016 Apr;95(4):256-69. doi: 10.1097/PHM.0000000000000370.

    PMID: 26368833BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Aruba Saeed, Phd*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Randomized control trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 15, 2024

Study Start

July 10, 2024

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations