search
Back to results

Mental Imagery for Lower Limb Functions

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mental imagery technique
Virtual Reality technique
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Stroke patients (both genders) Age 40-60 years Patients with sub-acute/ chronic stroke (>3 months) Modified Ashworth Ranking Scale 1-3 MOCA scoring >24-30 Exclusion Criteria: Any active pathological condition Visual or hearing impairment Orthopedic issues hindering Mobility Substantially (Fractures, Severe Degenerative Joint Diseases etc.) Psychological issues

Sites / Locations

  • Railway General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mental Imagery

Virtual Reality

Arm Description

For mental imagery, the calm and nice atmosphere isrequired for the patientsto focus on the details while sitting on a chair. The audiotape and headphones are given to the patients. The audiotape tape comprised of three phases. The first phase is relaxation phase. The patient has to do the first phase actively. In this phase patients have asked to do the deep breathing exercises while sitting on a chair and then contract their lower limb muscles from distal to proximal. The second phase is task-oriented phase. The patient has to imagine him performing the tasks.

The virtual reality training will be given through Kinect connected with Xbox 360. The Xbox games used are 20,000 water leaks, reflex ridge and river rush. The spacious environment will be given and walker are sometimes required for assistance. The LED and system are 3 feet away from patients. The VR training will be given to the both control and experimental groups

Outcomes

Primary Outcome Measures

Fugl Meyer Assessment Scale - Lower Extremity
This scale is recognized as a golden standard for assessment of motor function of stroke patients worldwide. It focuses on reflex activity, voluntary movements within and outside of synergies, ability to perform isolated movement, and coordination
Berg Balance Scale
In elderly Population, BBS is most commonly used outcome measure for functional balance. It is 14 Item balance measure scored on 5-point ordinal scale with range of 0 to 4, where high score indicates good balance & decreased risk of fall and vice versa. A maximum score of 56 is achievable
Timed Up and Go test
It is used to assess functional mobility; the risk of fall and dynamic balance can also be determined. In TUG test, the participant is asked to get up from a chair, walk a distance of 3 meters at Regular pace, turn around, walk a distance of 3 meter back to the chair and sit down
10-meter walk test
In this test, the participant walks through a 10-m walkway without any break. At the 4- m of walkway, time is recorded in order to obtain a rhythmic phase of walking speed
Wisconsin Gait Scale
This scale is used to assess gait cycle. It consists of 14 items, the higher the score, greater will be the disability. These scale focuses on the components of stance phase, guardedness of affected leg, toe off, swing phase and heel strike

Secondary Outcome Measures

Full Information

First Posted
March 31, 2023
Last Updated
March 31, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05812638
Brief Title
Mental Imagery for Lower Limb Functions
Official Title
Effects of Mental Imagery With Virtual Reality Training on Lower Limb Functions in Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Stroke is a neurological impairment occurs due to cardiovascular abnormality and cerebrovascular disease. The term 'stroke' is mostly used when there is sudden loss of function of the body due any abrupt changes.The rates of disability are increasing along with mortality and morbidity rates due to stroke. The poor motor performance of lower limb affects gait severely. The slow velocity and other gait deviations limit the stroke survivors' ability to perform ADL's and interfere with their quality of life. Hence, rehabilitation is obligatory for these patients to improve their quality of life
Detailed Description
motor imagery is helpful in improving mobility in healthy and neurologically impaired patients. When the patient is asked to do a movement, for example the patient is asked to walk along a draw line and then that patient has to imagine this same action in kinesthetic imagery. Neuroimaging shows that brain areas are more or less activated in the same manner. It can be concluded that there is some relation between mental imagery ability and muscular actions. In the stroke patients who have intact ability of mental imagery show activation of cortical areas demonstrating its ability to activate sub cortical areas also. Therefore, these results amplify the concept of using mental imagery for rehabilitation purpose of even deep lesion in motor nervous system.

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
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mental Imagery
Arm Type
Experimental
Arm Description
For mental imagery, the calm and nice atmosphere isrequired for the patientsto focus on the details while sitting on a chair. The audiotape and headphones are given to the patients. The audiotape tape comprised of three phases. The first phase is relaxation phase. The patient has to do the first phase actively. In this phase patients have asked to do the deep breathing exercises while sitting on a chair and then contract their lower limb muscles from distal to proximal. The second phase is task-oriented phase. The patient has to imagine him performing the tasks.
Arm Title
Virtual Reality
Arm Type
Active Comparator
Arm Description
The virtual reality training will be given through Kinect connected with Xbox 360. The Xbox games used are 20,000 water leaks, reflex ridge and river rush. The spacious environment will be given and walker are sometimes required for assistance. The LED and system are 3 feet away from patients. The VR training will be given to the both control and experimental groups
Intervention Type
Other
Intervention Name(s)
Mental imagery technique
Intervention Description
Warm up Period Mental Imagery (Sit-stand task Static stance (30 seconds) Indoor walk on a leveled surface Walk indoor towards target Forward / Side Stepping) Walk outdoors
Intervention Type
Other
Intervention Name(s)
Virtual Reality technique
Intervention Description
Virtual reality training (River rush, 20000 water leaks, reflex ridge.)
Primary Outcome Measure Information:
Title
Fugl Meyer Assessment Scale - Lower Extremity
Description
This scale is recognized as a golden standard for assessment of motor function of stroke patients worldwide. It focuses on reflex activity, voluntary movements within and outside of synergies, ability to perform isolated movement, and coordination
Time Frame
week 6
Title
Berg Balance Scale
Description
In elderly Population, BBS is most commonly used outcome measure for functional balance. It is 14 Item balance measure scored on 5-point ordinal scale with range of 0 to 4, where high score indicates good balance & decreased risk of fall and vice versa. A maximum score of 56 is achievable
Time Frame
week 6
Title
Timed Up and Go test
Description
It is used to assess functional mobility; the risk of fall and dynamic balance can also be determined. In TUG test, the participant is asked to get up from a chair, walk a distance of 3 meters at Regular pace, turn around, walk a distance of 3 meter back to the chair and sit down
Time Frame
week 6
Title
10-meter walk test
Description
In this test, the participant walks through a 10-m walkway without any break. At the 4- m of walkway, time is recorded in order to obtain a rhythmic phase of walking speed
Time Frame
week 6
Title
Wisconsin Gait Scale
Description
This scale is used to assess gait cycle. It consists of 14 items, the higher the score, greater will be the disability. These scale focuses on the components of stance phase, guardedness of affected leg, toe off, swing phase and heel strike
Time Frame
week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stroke patients (both genders) Age 40-60 years Patients with sub-acute/ chronic stroke (>3 months) Modified Ashworth Ranking Scale 1-3 MOCA scoring >24-30 Exclusion Criteria: Any active pathological condition Visual or hearing impairment Orthopedic issues hindering Mobility Substantially (Fractures, Severe Degenerative Joint Diseases etc.) Psychological issues
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arshad Malik, PhD
Phone
+92 333 4503754
Email
arshad.nawaz@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
arshad Malik, Phd
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Railway General Hospital
City
Rawalpindi
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tasmiya Asghar, DPT

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mental Imagery for Lower Limb Functions

We'll reach out to this number within 24 hrs