Task-oriented Balance Training With Sensory Integration

July 8, 2020 updated by: Riphah International University

Effects of Task-oriented Balance Training With Sensory Integration in Post-stroke Patients.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Stroke is the leading cause of high levels of morbidity and long-term functional disability in adults. Stroke is a clinical syndrome characterized by rapidly developing symptoms and/or signs of focal and at times global (for patients in Coma) loss of cerebral functions, with symptoms lasting more than 24 hours or leading to death with no apparent cause other than that of vascular origin. The incident of stroke is rising steadily, According to estimates by the WHO, stroke accounted for 5.7 million deaths and 16 million first-time events in 2005 and these numbers may reach 7.8 million and 23 million by 2030, respectively. Stroke is the second leading cause of preventable death worldwide and the fourth leading cause of lost productivity, as measured by disability-adjusted life years. World Health Organization reported that total mortality due to stroke in Pakistan was 78512.2 WHO estimate for the year 2020 predict that stroke will remain the second leading cause of death after ischemic heart disease, both in developing and developed countries. Annually, fifteen millions people worldwide suffer a stroke. Of these, five million dies and another five million are left permanently disabled, placing a burden on family and community. When balance impairment is affected early after stroke, performance of simple and complex tasks become difficult which results in their functional mobility. Impaired balance has also been identified as the strongest predictor of falling, which in turn is related to fear of falling, limited activity and quality of life. Thus, this vicious cycle of balance disability is continued, resulting in delaying the recovery process of stroke rehabilitation. Sensory impairment reduces sensory processing ability, thereby reducing motor and balance responses. Muscle weakness causes a muscular imbalance between the paretic and non-paretic sides, resulting in weight-bearing imbalance and an asymmetric posture during standing. As a result, functional activities such as sit-to-stand, standing, walking, and balance control are limited. Different interventions were used for the restoration of functional activities mobility and balance in post-stroke patients. A task-oriented approach is one method used to overcome limited functional activities. Previous studies have reported that the application of this approach was effective in improving functional activities in stroke patients. Shumway-Cook and Woollacott reported that movements are generated by the interaction of various systems in the brain, organized with a focus on goals, and limited by the environment. Because the task-oriented approach focuses on goals and the environment, it may be a suitable method for overcoming limited functional activities. The effective integration of visual, somatosensory, and vestibular information is necessary to maintain balance ability during functional activities. Stroke patients rely highly on visual information due to a lack of somatic and vestibular senses. Therefore, it is necessary to restore sensory integration in stroke patients through the manipulation of somatic, visual and vestibular senses. Task-oriented balance training is proved to be effective for improvement of balance in stroke patients. Sensory balance training has also shown a beneficial effect on balance and mobility of stroke patients. There is limited evidence on the effects gained by task-oriented balance training with altered sensory input This study aims to determine the effects gained by combining the task-oriented balance training with sensory integration.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 44000
        • Riphah International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: balance training with sensory integration group
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

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
EXPERIMENTAL: balance training without sensory integration group
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

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Berg balance scale (BBS)
Time Frame: From baseline to 6th week
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)
Time Frame: From baseline to 6th week
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)
Time Frame: From baseline to 6th week
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
Time Frame: From baseline to 6th week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/00558 Sohail Iqbal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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