- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04894773
Effects of Imaginary Resisted Exercise Versus Physical Resisted Exercise on Hand Grip Strength in Stroke Patients
Effects of Imaginary Resisted Exercise Versus Physical Resisted Exercise on Hand Grip Strength in Stroke Patients: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A Randomized Control Trial study will be conducted in which patients with stroke will be allocated to Group A that will receive imaginary resistance exercises and patients in group B will receive physical resistance exercises.
The intervention will be applied (3 days /week) for 12 weeks, which consists of 5 different types of resistance using 5 different resistive objects, each will have 15 repetitions. Each session includes handgrip exercises with physical resistance exercises for one group and imaginary resistance exercises using Virtual Reality Box for another group. As for improving dexterity and eye-hand coordination, the Purdue pegboard test and finger-to-nose test will be used respectively in both groups with 15-15 repetitions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Faisalabad, Punjab, Pakistan, 38000
- Ripah International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age should be in the range from 50 years to 75 years
- Time passed since stroke attack should be more than one year.
- Grade of Manual Muscles Testing for Elbow and Wrist, Flexion / Extension should be more than 2 out of 5.
- Scoring of Modified Ashworth Scale should be more than 3 out of 5 for the same muscle groups of previously mentioned movements.
Exclusion Criteria:
- Any significant pain present in the affected upper limb.
- Increased muscle tone that interferes with movements of the affected upper limb.
- Serious sensory loss in the affected upper limb.
- Severe medical issues currently.
- Cognitive impairment to a level that interferes with sessions of intervention.
- Impairments of vision that disables patient to perform interventional exercises.
- Serious presence of apraxia / neglect.
- If enrolled for any related or alike other upper limb therapy sessions / interventional studies.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Imaginary Resisted Exercises
Handgrip exercises with the imagination of resistance in hand by getting feedback in VR Box will be given as an intervention.
Stretching will be given at the beginning and the end of each session.
This will include imaginary resistance exercises for handgrip by using Virtual Reality Box.
Five types of different resistances will be imagined by patients by watching their own videos in VR box, which will be recorded on day one to make them familiar with the resistive objects and the resistance experienced from them by asking patients to perform 15-15 repetitions of each object.
Every imaginary resistance exercise will have 15 repetitions.
After performing exercises, the participants will ask to perform Finger-to-Nose Test and Purdue Pegboard Test.
|
In imaginary resistance exercises, resistive force is assumed to get applied by the patient after demonstrating some resistive objects and the kind of force exerted by them.
Other Names:
|
Experimental: Physical Resisted Exercises
Handgrip exercises with physical resistance in hand will be given as an intervention.
Stretching will be given at the beginning and the end of the session.
5 different types of resistances will be given to patients for making themselves familiarize themselves with the type of resistance applied by each object, that they will experience in further sessions, by asking them to perform 15-15 repetitions of each object.
Every physical resistance exercise will have 15 repetitions.
After performing exercises, the participants will ask to perform Finger-to-Nose Test and Purdue Pegboard Test.
|
In physical resistance exercises, resistive force is applied to the targeted region by using different and appropriate resistive objects.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goniometer
Time Frame: 12th Week
|
Goniometer has been the most widely used tool for measuring joint range of motion.
To ensure reliable measurement, standardized, specific positions and landmarks are used to measure each joint movement.
|
12th Week
|
Hydraulic Hand Dynamometer
Time Frame: 12th Week
|
It is an isometric instrument that can provide the most stable results during repetitive gripping exercises.
This instrument has been reported to have high validity and reliability.
This is considered to be a "Gold Standard" instrument, and many researchers have used the Jamar as a standard to validate other instruments.
|
12th Week
|
Purdue Peg Board Test
Time Frame: 12th Week
|
It is a functional assessment tool to screen for hand dexterity.
It was designed to assess fine motor hand function using three common objects, pegs, washers, and collars, to be inserted on a pegboard.
With its long history and wide usage, its reliability in healthy subjects is well established because it employs tasks that resemble activities of daily living.
It is economical and easy to administer
|
12th Week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Muhammad Kashif, Riphah International University
Publications and helpful links
General Publications
- Friedman N, Chan V, Reinkensmeyer AN, Beroukhim A, Zambrano GJ, Bachman M, Reinkensmeyer DJ. Retraining and assessing hand movement after stroke using the MusicGlove: comparison with conventional hand therapy and isometric grip training. J Neuroeng Rehabil. 2014 Apr 30;11:76. doi: 10.1186/1743-0003-11-76.
- Allen D, Barnett F. Reliability and validity of an electronic dynamometer for measuring grip strength. International Journal of Therapy and Rehabilitation. 2011;18(5):258-64.
- Amirjani N, Ashworth NL, Olson JL, Morhart M, Chan KM. Validity and reliability of the Purdue Pegboard Test in carpal tunnel syndrome. Muscle Nerve. 2011 Feb;43(2):171-7. doi: 10.1002/mus.21856. Epub 2010 Nov 24.
- Johansson GM, Grip H, Levin MF, Hager CK. The added value of kinematic evaluation of the timed finger-to-nose test in persons post-stroke. J Neuroeng Rehabil. 2017 Feb 10;14(1):11. doi: 10.1186/s12984-017-0220-7.
- Jones A, Sealey R, Crowe M, Gordon S. Concurrent validity and reliability of the Simple Goniometer iPhone app compared with the Universal Goniometer. Physiother Theory Pract. 2014 Oct;30(7):512-6. doi: 10.3109/09593985.2014.900835. Epub 2014 Mar 25.
- Lambiase MJ, Kubzansky LD, Thurston RC. Prospective study of anxiety and incident stroke. Stroke. 2014 Feb;45(2):438-43. doi: 10.1161/STROKEAHA.113.003741. Epub 2013 Dec 19.
- Coroian F, Jourdan C, Bakhti K, Palayer C, Jaussent A, Picot MC, Mottet D, Julia M, Bonnin HY, Laffont I. Upper Limb Isokinetic Strengthening Versus Passive Mobilization in Patients With Chronic Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):321-328. doi: 10.1016/j.apmr.2017.08.490. Epub 2017 Sep 22.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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/FSD/0234
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 Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on Imaginary Resistance Exercises
-
Riphah International UniversityRecruitingHemiplegic Cerebral PalsyPakistan
-
Cairo UniversityActive, not recruiting
-
Dow University of Health SciencesRecruiting
-
Federal University of São PauloCompletedShoulder Impingement SyndromeBrazil
-
Riphah International UniversityCompleted
-
University of BrasiliaMilitary Fire Department of the Federal DistrictWithdrawn
-
Qassim UniversityCompleted
-
Ziauddin UniversityCompleted
-
Centro Universitario La SalleUnknown