Effectiveness of Perturbations Exercises in Improving Balance, Function and Mobility in Stroke Patients (perturbation)

July 26, 2017 updated by: Nawaj Pathan, Mahatma Gandhi Institute of Medical Sciences

Effectiveness of Perturbations Exercises in Improving Balance, Function and Mobility in Stroke Patients.

Following stroke, patients loses functions of the motor, sensory and higher brain cognitive faculties to various degrees which lead to diminished balance. It has been documented that hemiplegic or hemiparetic stroke patients presented with more posture sway, asymmetric weight distribution, impaired weight-shifting ability and decreased stability capability. There are many balance exercises and strategies; to improve balance in elderly age group population, to prevent fall prevention. But we have very few evidences of giving manual perturbation balance training in stroke patients to improve speed, balance and function. Therefore this study is taken up to examine whether the manual perturbation balance training is more effective in improving speed, balance and function in stroke patients.

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

There are many more studies done for elderly populations, normal individuals for improving balance by giving perturbation based balance training.All perturbation exercises are given by either mechanical or by self reaching tasks in forward,backward,and in both sideways. There are very studies ;who attempted perturbation based balance training to improve balance in elderly population but not for stroke patients for their Speed, Balance and Function.The manual perturbation exercise can be an promising intervention in the future for various conditions

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.
30

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

  • India
    • Maharashtra
      • Aurangabad, Maharashtra, India, 431003
        • MGM School Of Physiotherapy

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

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. First ever stroke
  2. Age ranges between 40-70
  3. Both genders were included
  4. Ambulatory patients with or without ambulatory aids
  5. Occurrence of stroke at within 0-3 months i.e.-sub acute
  6. Able to follow command
  7. Mini mental scale examinations not less than 24

Exclusion Criteria:

  1. Patients who has severe limitations in passive range of motion at lower extremities
  2. Patients with impaired sensory, proprioceptor, cognitive and perceptual ability
  3. Patient who has contracture
  4. Orthopedic or any other neurological disorder which impair balance

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: Crossover Assignment
  • 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: Experimental Group
manual perturbations were given in forward, Backward,right and left sideways, 10 perturbations were given,6 days in week,in fallowing positions- sitting,kneeling, standing positions
Other: Perturbation
Manual perturbations were given at waist region,over the Shoulders. in following positions- sitting, kneeling, standing positions,10 perturbations were given in forward,backward,both right and left side, 6 days in a week all precautionary measures taken for the patient's safety
Other Names:
  • Manual Perturbation
Other: Conventional Physiotherapy Treatment
Conventional Physiotherapy treatment were given to participants included in this group for 30 mins daily for 4 weeks
Other Names:
  • control Group
Placebo Comparator: Control group
Conventional Physiotherapy were given 6 days in a week, for 30 mins for 4 weeks, includes stretching, strengthening of contralateral limbs
Other: Perturbation
Manual perturbations were given at waist region,over the Shoulders. in following positions- sitting, kneeling, standing positions,10 perturbations were given in forward,backward,both right and left side, 6 days in a week all precautionary measures taken for the patient's safety
Other Names:
  • Manual Perturbation
Other: Conventional Physiotherapy Treatment
Conventional Physiotherapy treatment were given to participants included in this group for 30 mins daily for 4 weeks
Other Names:
  • control Group

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
Time Frame: 4 weeks
patients ability of balance were assessed
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Independence Scale
Time Frame: 4 weeks
ability of Functional independent level for Activity Of Daily Living were assessed
4 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Timed Up and Go Test
Time Frame: 4 weeks
patient's speed for performing Activity Of Daily Living were assessed by this test
4 weeks

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.
Mahatma Gandhi Institute of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nawaj Pathan, PG student, MGM School Of Physiotherapy,Aurangabad,Maharashtra, India

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

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.
January 1, 2014

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 1, 2014

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.
December 1, 2014

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).
December 10, 2014

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 26, 2017

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 31, 2017

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 31, 2017

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 26, 2017

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, 2017

More Information

Terms related to this study

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.
  • MGM ECRHS 2014/160

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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