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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Perturbation
Conventional Physiotherapy Treatment
Sponsored by
Mahatma Gandhi Institute of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • MGM school Of Physiotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Group

Control group

Arm Description

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

Conventional Physiotherapy were given 6 days in a week, for 30 mins for 4 weeks, includes stretching, strengthening of contralateral limbs

Outcomes

Primary Outcome Measures

Berg Balance Scale
patients ability of balance were assessed

Secondary Outcome Measures

Functional Independence Scale
ability of Functional independent level for Activity Of Daily Living were assessed

Full Information

First Posted
December 10, 2014
Last Updated
July 26, 2017
Sponsor
Mahatma Gandhi Institute of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03234426
Brief Title
Effectiveness of Perturbations Exercises in Improving Balance, Function and Mobility in Stroke Patients
Acronym
perturbation
Official Title
Effectiveness of Perturbations Exercises in Improving Balance, Function and Mobility in Stroke Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahatma Gandhi Institute of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Conventional Physiotherapy were given 6 days in a week, for 30 mins for 4 weeks, includes stretching, strengthening of contralateral limbs
Intervention Type
Other
Intervention Name(s)
Perturbation
Other Intervention Name(s)
Manual Perturbation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy Treatment
Other Intervention Name(s)
control Group
Intervention Description
Conventional Physiotherapy treatment were given to participants included in this group for 30 mins daily for 4 weeks
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
patients ability of balance were assessed
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Functional Independence Scale
Description
ability of Functional independent level for Activity Of Daily Living were assessed
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Timed Up and Go Test
Description
patient's speed for performing Activity Of Daily Living were assessed by this test
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: First ever stroke Age ranges between 40-70 Both genders were included Ambulatory patients with or without ambulatory aids Occurrence of stroke at within 0-3 months i.e.-sub acute Able to follow command Mini mental scale examinations not less than 24 Exclusion Criteria: Patients who has severe limitations in passive range of motion at lower extremities Patients with impaired sensory, proprioceptor, cognitive and perceptual ability Patient who has contracture Orthopedic or any other neurological disorder which impair balance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nawaj Pathan, PG student
Organizational Affiliation
MGM School Of Physiotherapy,Aurangabad,Maharashtra, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGM school Of Physiotherapy
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431003
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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