- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05812638
Mental Imagery for Lower Limb Functions
Effects of Mental Imagery With Virtual Reality Training on Lower Limb Functions in Stroke
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arshad Malik, PhD
- Phone Number: +92 333 4503754
- Email: arshad.nawaz@riphah.edu.pk
Study Locations
-
-
-
Rawalpindi, Pakistan
- Recruiting
- Railway General Hospital
-
Contact:
- Tasmiya Asghar, DPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mental Imagery
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.
|
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
|
|
Active Comparator: Virtual Reality
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 |
Virtual reality training (River rush, 20000 water leaks, reflex ridge.)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl Meyer Assessment Scale - Lower Extremity
Time Frame: week 6
|
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
|
week 6
|
|
Berg Balance Scale
Time Frame: week 6
|
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 |
week 6
|
|
Timed Up and Go test
Time Frame: week 6
|
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
|
week 6
|
|
10-meter walk test
Time Frame: week 6
|
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
|
week 6
|
|
Wisconsin Gait Scale
Time Frame: week 6
|
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
|
week 6
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: arshad Malik, Phd, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/01261 Tasmiya
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Stroke
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
National Assembly ClinicBayero University Kano, NigeriaCompletedStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea
-
University Hospital HeidelbergCompletedAcute Ischemic Stroke | Acute Ischemic Stroke AIS | Acute Ischemic Stroke PatientsGermany
Clinical Trials on Mental imagery technique
-
Marquette UniversityRecruitingAnterior Cruciate Ligament ReconstructionUnited States
-
Ariel UniversityLoewenstein HospitalCompletedTranstibial Amputation | Transtibial Amputation - Unilateral | Transtibial AmputeeIsrael
-
Centre Hospitalier Universitaire de NīmesCompletedSimulation Training | Mental Imagery | Peripheral Venous CatheterizationFrance
-
University of Central FloridaCompletedResistance TrainingUnited States
-
University of AberdeenChief Scientist Office of the Scottish GovernmentCompleted
-
University of East LondonUniversity of ManchesterUnknownCovid19 | Viral InfectionUnited Kingdom
-
University of West AtticaAlzheimer's AssociationRecruiting
-
Universiti Tunku Abdul RahmanCompleted