Effectiveness of Perturbations Exercises in Improving Bal... | NCT03234426

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

NCT03234426

Sponsor

Mahatma Gandhi Institute of Medical Sciences

Status

Completed

Last Update Posted

Jul 31, 2017Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Stroke

Interventions

Perturbation
Conventional Physiotherapy Treatment

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Dec 10, 2014

First Submission Date that Met QC Criteria

Jul 26, 2017

First Posted Date

Jul 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2017

Last Update Posted Date

Jul 31, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nawaj Pathan, M.P.Th.PG student, Mahatma Gandhi Institute of Medical SciencesPrincipal Investigator

Lead Sponsor

Mahatma Gandhi Institute of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Group	Experimental	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 Other: Conventional Physiotherapy Treatment
Control group	Placebo Comparator	Conventional Physiotherapy were given 6 days in a week, for 30 mins for 4 weeks, includes stretching, strengthening of contralateral limbs	Other: Perturbation Other: Conventional Physiotherapy Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Perturbation	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Berg Balance Scale	patients ability of balance were assessed	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Functional Independence Scale	ability of Functional independent level for Activity Of Daily Living were assessed	4 weeks

Other Outcomes

Measure	Description	Time Frame
Timed Up and Go Test	patient's speed for performing Activity Of Daily Living were assessed by this test	4 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nawaj Pathan, PG student	MGM School Of Physiotherapy,Aurangabad,Maharashtra, India	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MGM school Of Physiotherapy		Aurangabad	Maharashtra	431003	India

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D035061	Control Groups

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Browse Leaves

Not provided

Browse Branches

Not provided