NCT04468269

Brief Summary

Objectives of this study are to determine the effect of task-oriented balance training on balance, postural stability and mobility in Stroke patients, to determine the effect of task-oriented balance training with sensory integration on balance, postural stability and mobility in post Stroke patients and to compare the effect of balance training with and without sensory integration on balance, postural stability and mobility in stroke patients. Study Design is Randomized control trial. Sample Size is 60 calculated through open Epi tool. Sampling Technique is Non-probability purposive sampling technique then randomization through sealed envelope method into control and experimental group. Duration of study is 6 months. Study Setting Rafsan Stroke Center Peshawar.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 15, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

July 8, 2020

Last Update Submit

July 8, 2020

Conditions

Keywords

task oriented balance trainingsensory integrationstroke patients.

Outcome Measures

Primary Outcomes (4)

  • Berg balance scale (BBS)

    The Berg balance scale (BBS) is used to assess the participant's ability to retain stability The BBS is a widely used test for the assessment of elderly population with impairment of balance and individuals with neurological disorder while sitting, standing, and transferring. This test included both static and dynamic type task. The BBS uses a five-point ordinal scale ranging from 0 (disability) to 4(complete independent performance) and consists of 14 components; the maximum score is 56 points.A score of 56 indicates functional balance.A score of \< 45 indicates individuals may be at greater risk of falling

    From baseline to 6th week

  • Balance error scoring system (BESS)

    It is objective method of assessing static postural stability. Subjects are asked to perform Double leg stance, Single leg stance, Tandem Stance on firm surface and then on foam surface. The numbers of errors during performance of these tasks are assessed.

    From baseline to 6th week

  • The Activities-specific Balance Confidence (ABC)

    Activities-specific balance confidence (ABC) scale is 16 items scale it is a subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. Items are rated on a rating scale that ranges from 0-100. The overall score was calculated by adding item scores and then divided by a total number of items.

    From baseline to 6th week

  • Dynamic Gait Index

    It is an 8-item test. Developed to assess the likelihood of falling in older adults A four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function. Total Score of this test is 24.Score\< 19/24 = is a predictive risk of falls.

    From baseline to 6th week

Study Arms (2)

balance training with sensory integration group

EXPERIMENTAL

Conventional treatment: Static stretching exercises such as trunk rotation, flexion, and extension; hip flexors stretch, standing hamstring stretch; plantar flexors stretch, shoulder, elbow and wrist flexors and supinators stretch. Stretching will be applied for 30-sec hold with 30-sec rest. 3-5 times for each muscle group. For 40 min/day and 3 days/week for 6 weeks to improve balance and postural stability.

Other: Task oriented balance training with sensory integration group

balance training without sensory integration group

EXPERIMENTAL

Conventional treatment: Static stretching exercises such as trunk rotation, flexion, and extension; hip flexors stretch, standing hamstring stretch; plantar flexors stretch, shoulder, elbow and wrist flexors and supinators stretch. Stretching will be applied for 30-sec hold with 30-sec rest. 3-5 times for each muscle group.For 40 min/day and 3 days/week for 6 weeks to improve balance and postural stability

Other: Task oriented balance training without sensory integration group

Interventions

Sitting position: 1. Sit in a chair without backrest while keeping the feet on floor. 2. Sit on a ball while keeping the feet on the floor. Sit to stand: 1. Sit in a chair without a backrest 2. Sit in a chair without a backrest with and perform the sit-to-stand motion repeatedly. 3. Sit on a ball and perform the sit-to-stand motion repeatedly. Standing position: Perform bipedal standing Control Of Weight Shifting. Perform a semi-tandem stance. One Foot Standing. Walking: 1. Walk forward 2. Walk forward cross an obstacle, and then continue to walk. 3. Walk Lateral 4. Walk Backward 5. Tandem walk

balance training with sensory integration group

Sitting position: 1. Sit in a chair without a backrest while keeping the feet on a firm surface. 2. Sit on a ball while keeping the feet on the firm surface Sit to stand: 1. Sit in a chair without a backrest with the feet on a firm surface and perform the sit-to-stand motion repeatedly. 2. Sit on a ball with the feet on the firm surface and perform the sit-to-stand motion repeatedly. Standing position: 1. Perform bipedal standing on a firm surface. 2. Perform a semi-tandem stance on the firm surface Walking: 1. Walk forward on a firm surface. 2. Walk forward on the firm surface, cross an obstacle, and then continue to walk. 3. Walk sideways 4. Walk Backward 5. Tandem walk

balance training without sensory integration group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • At least 6 months post stroke,
  • Stability of neurological severity
  • An ability to understand and perform the test
  • Ability to maintain standing position without aids for at least 5 minutes
  • GRADE II, III, IV on Functional mobility Scale.

You may not qualify if:

  • Posterior circulation stroke
  • Deficits of somatic sensation involving the paretic lower limb
  • Presence of severe Hemiplegia
  • Vestibular disorders, paroxysmal vertigo
  • Presence of other neurological conditions such as neglect, hemianopsia and pushing syndrome
  • Presence of orthopedic diseases involving the lower limbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, 44000, Pakistan

Location

Related Publications (7)

  • Walker C, Brouwer BJ, Culham EG. Use of visual feedback in retraining balance following acute stroke. Phys Ther. 2000 Sep;80(9):886-95.

    PMID: 10960936BACKGROUND
  • Park MH, Won JI. The effects of task-oriented training with altered sensory input on balance in patients with chronic stroke. J Phys Ther Sci. 2017 Jul;29(7):1208-1211. doi: 10.1589/jpts.29.1208. Epub 2017 Jul 15.

    PMID: 28744049BACKGROUND
  • Lamb SE, Ferrucci L, Volapto S, Fried LP, Guralnik JM; Women's Health and Aging Study. Risk factors for falling in home-dwelling older women with stroke: the Women's Health and Aging Study. Stroke. 2003 Feb;34(2):494-501.

    PMID: 12574566BACKGROUND
  • Kuklina EV, Tong X, George MG, Bansil P. Epidemiology and prevention of stroke: a worldwide perspective. Expert Rev Neurother. 2012 Feb;12(2):199-208. doi: 10.1586/ern.11.99.

    PMID: 22288675BACKGROUND
  • Bayouk JF, Boucher JP, Leroux A. Balance training following stroke: effects of task-oriented exercises with and without altered sensory input. Int J Rehabil Res. 2006 Mar;29(1):51-9. doi: 10.1097/01.mrr.0000192100.67425.84.

    PMID: 16432390BACKGROUND
  • Dean CM, Shepherd RB. Task-related training improves performance of seated reaching tasks after stroke. A randomized controlled trial. Stroke. 1997 Apr;28(4):722-8. doi: 10.1161/01.str.28.4.722.

    PMID: 9099186BACKGROUND
  • Bonan IV, Colle FM, Guichard JP, Vicaut E, Eisenfisz M, Tran Ba Huy P, Yelnik AP. Reliance on visual information after stroke. Part I: Balance on dynamic posturography. Arch Phys Med Rehabil. 2004 Feb;85(2):268-73. doi: 10.1016/j.apmr.2003.06.017.

    PMID: 14966712BACKGROUND

Study Officials

  • Aruba Saeed, PHD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 13, 2020

Study Start

June 15, 2019

Primary Completion

December 15, 2019

Study Completion

January 15, 2020

Last Updated

July 13, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations