Back to resultsMotor Imagery Technique on Lower Limb Function Among Stroke Patients.
Primary Purpose
Spasticity as Sequela of Stroke, Gait, Hemiplegic, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Motor imagery technique
Conventional Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Spasticity as Sequela of Stroke focused on measuring Gait, Lower Limb function, Motor imagery
Eligibility Criteria
Inclusion Criteria:
- Adult without ADHD by Adult ADHD Self-Report Scale score.
- History of no more than one stroke.
- Lower limb muscles spasticity with the grade 1+ or 2 on modified Ashworth in scale.
- Mini-mental status score more than 25.
- Patients who are less than 6 months post-stroke.
- Modified Rankin scale score is 4.
Exclusion Criteria:
- Lesion of frontal, parietal and basal ganglia
- Excessive spasticity that is score of>3 on modified Ashworth spasticity scale.
- Any musculoskeletal disorder impeding lower limb function.
- Participating in any experimental rehabilitation or drug studies.
- Bed ridden patient.
- Subjects psychiatric disorder or dementia.
- Any neglect of space on the affected side, or any other neurological disease or auditory or visual.
Sites / Locations
- Bibi Zahida Memorial Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Motor imagery technique
Conventional Physical therapy
Arm Description
Motor Imagery technique Plus Conventional Physical therapy
passive stretching, ROM exercises, sitting to standing, anteroposterior step, climbing and descending stairs.
Outcomes
Primary Outcome Measures
Lower Extremity Function scale
It is 20 items questionnaire, measure the lower extremity function scoring from 1 to 4 for each items, in which minimum score is 0 and maximum score of 80 shows the maximum functional status. It has a valid and reliable tool to measure the lower extremity functional status.
Dynamic Gait Index
It assess gait, balance and fall risk, with 24 is the maximum score, in which 19 or less have been related to increase incidence of falls. It has high reliability and validity in the stroke population.
Time Up and Go test
It assess a person's mobility and requires both static and dynamic balance. Score of less than 10 seconds indicate freely mobile,<20 seconds mostly independent, 20-29 seconds variable mobility, >30 seconds Impaired mobility. It is reliable, valid, and easy to administer clinical tool in stroke patients.
Stroke Specific Quality of Life Scale
It is a self-report questionnaire, measure the quality of life in stroke patients consisting of 49 items in the 12 domains. Scoring from 1 to 5 , in which 1 shows strongly agreement and 5 shows strongly disagreement. It is a reliable and valid tool for measuring the quality of life for stroke patients.
Modified Ashworth scale
It measures the spasticity, ranging from 0 means normal tone to 4 shows increased tone to such extent where passive movement is not possible. It has good intra-rater reliability and validity in stroke patients .
Secondary Outcome Measures
Full Information
NCT ID
NCT04707755
First Posted
January 12, 2021
Last Updated
January 12, 2021
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04707755
Brief Title
Motor Imagery Technique on Lower Limb Function Among Stroke Patients.
Official Title
Effects of Motor Imagery Technique on Lower Limb Function Among Stroke Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 30, 2020 (Actual)
Primary Completion Date
November 28, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
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
To determine the effects of motor imagery technique on lower limb function among stroke patient.
To determine the effects of motor imagery technique on lower limb spasticity among stroke patients.
To determine the effects of motor imagery technique on gait among stroke patients.
To determine the effects of motor imagery technique on quality of life among stroke patients
Detailed Description
Stroke affected the functional capacities and the state of health thus altered quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasticity as Sequela of Stroke, Gait, Hemiplegic, Quality of Life
Keywords
Gait, Lower Limb function, Motor imagery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Motor imagery technique
Arm Type
Experimental
Arm Description
Motor Imagery technique Plus Conventional Physical therapy
Arm Title
Conventional Physical therapy
Arm Type
Active Comparator
Arm Description
passive stretching, ROM exercises, sitting to standing, anteroposterior step, climbing and descending stairs.
Intervention Type
Other
Intervention Name(s)
Motor imagery technique
Intervention Description
The patient will sit on chair in a quiet room. The patients will be observing motor performance in video, motor performance video will consist of (1) knee flexion and extension movement, (2) sitting to standing movement, (3) stepping movement, (4) walking, (5) climbing and descending stairs.
Addition to motor imagery, the patients will be provided the passive stretching, ROM exercises, sitting to standing, anteroposterior step, climbing and descending stairs.
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
It includes passive stretching, ROM exercises, sitting to standing, anteroposterior step, climbing and descending stairs.
Primary Outcome Measure Information:
Title
Lower Extremity Function scale
Description
It is 20 items questionnaire, measure the lower extremity function scoring from 1 to 4 for each items, in which minimum score is 0 and maximum score of 80 shows the maximum functional status. It has a valid and reliable tool to measure the lower extremity functional status.
Time Frame
8 weeks
Title
Dynamic Gait Index
Description
It assess gait, balance and fall risk, with 24 is the maximum score, in which 19 or less have been related to increase incidence of falls. It has high reliability and validity in the stroke population.
Time Frame
8 weeks
Title
Time Up and Go test
Description
It assess a person's mobility and requires both static and dynamic balance. Score of less than 10 seconds indicate freely mobile,<20 seconds mostly independent, 20-29 seconds variable mobility, >30 seconds Impaired mobility. It is reliable, valid, and easy to administer clinical tool in stroke patients.
Time Frame
8 weeks
Title
Stroke Specific Quality of Life Scale
Description
It is a self-report questionnaire, measure the quality of life in stroke patients consisting of 49 items in the 12 domains. Scoring from 1 to 5 , in which 1 shows strongly agreement and 5 shows strongly disagreement. It is a reliable and valid tool for measuring the quality of life for stroke patients.
Time Frame
8 Weeks
Title
Modified Ashworth scale
Description
It measures the spasticity, ranging from 0 means normal tone to 4 shows increased tone to such extent where passive movement is not possible. It has good intra-rater reliability and validity in stroke patients .
Time Frame
8 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult without ADHD by Adult ADHD Self-Report Scale score.
History of no more than one stroke.
Lower limb muscles spasticity with the grade 1+ or 2 on modified Ashworth in scale.
Mini-mental status score more than 25.
Patients who are less than 6 months post-stroke.
Modified Rankin scale score is 4.
Exclusion Criteria:
Lesion of frontal, parietal and basal ganglia
Excessive spasticity that is score of>3 on modified Ashworth spasticity scale.
Any musculoskeletal disorder impeding lower limb function.
Participating in any experimental rehabilitation or drug studies.
Bed ridden patient.
Subjects psychiatric disorder or dementia.
Any neglect of space on the affected side, or any other neurological disease or auditory or visual.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirza Obaid Baig, MSPT(NMR)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bibi Zahida Memorial Teaching Hospital
City
Peshawar
State/Province
KPK
ZIP/Postal Code
251900
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Gul I, Malik MS, Halim A, Rauf S. POST STROKE DEPRESSION: EXPERIENCE AT A TERTIARY CARE HOSPITAL OF PAKISTAN. Pakistan Armed Forces Medical Journal. 2019 Aug 27;69(4):779-83.
Results Reference
background
PubMed Identifier
31412056
Citation
Paravlic AH, Pisot R, Marusic U. Specific and general adaptations following motor imagery practice focused on muscle strength in total knee arthroplasty rehabilitation: A randomized controlled trial. PLoS One. 2019 Aug 14;14(8):e0221089. doi: 10.1371/journal.pone.0221089. eCollection 2019.
Results Reference
background
PubMed Identifier
29344360
Citation
Pedersen SG, Heiberg GA, Nielsen JF, Friborg O, Stabel HH, Anke A, Arntzen C. Validity, reliability and Norwegian adaptation of the Stroke-Specific Quality of Life (SS-QOL) scale. SAGE Open Med. 2018 Jan 8;6:2050312117752031. doi: 10.1177/2050312117752031. eCollection 2018.
Results Reference
background
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Motor Imagery Technique on Lower Limb Function Among Stroke Patients.
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