StrokeNCT04894773
Effects of Imaginary Resisted Exercise Versus Physical Resisted Exercise on Hand Grip Strength in Stroke Patients
A study testing Imaginary Resistance Exercises and Physical Resisted Exercises in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
The goal of our study is to make a comparison between the effectiveness of physical resistance exercise and imaginary resistance exercise in improving handgrip strength, dexterity, and eye-hand coordination among stroke patients. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Stroke
- What is being tested?
- Imaginary Resistance Exercises and Physical Resisted Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: Effects of Imaginary Resisted Exercise Versus Physical Resisted Exercise on Hand Grip Strength in Stroke Patients: A Randomized Controlled Trial
The goal of our study is to make a comparison between the effectiveness of physical resistance exercise and imaginary resistance exercise in improving handgrip strength, dexterity, and eye-hand coordination among stroke patients.
Read the 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.
- Conditions
- Stroke
- Being tested
- Imaginary Resistance Exercises, Physical Resisted Exercises
- Keywords
- Stroke, Physical Resisted exercise, Imaginary Resisted exercise, Hand grip strength
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaginary Resistance ExercisesOther
Also called Rehabilitation following Imaginary Resistance Exercises
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.
Physical Resisted ExercisesOther
Also called Rehabilitation following Physical Resisted Exercises
In physical resistance exercises, resistive force is applied to the targeted region by using different and appropriate resistive objects.
| Study group | Role | What they receive |
|---|---|---|
| Imaginary Resisted Exercises | Experimental | 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. Receives: Other: Imaginary Resistance Exercises |
| Physical Resisted Exercises | Experimental | 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. Receives: Other: Physical Resisted Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydraulic Hand Dynamometer
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.
Measured: 12th Week
Purdue Peg Board Test
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
Measured: 12th Week
Goniometer
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.
Measured: 12th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 Mar 2021
- Primary completion30 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894773
- Sponsor's protocol ID
- REC/FSD/0234
- Status last verified
- Aug 2023
- First submitted
- 19 May 2021
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21254080Johansson 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.
PubMed 28183337Jones 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.
PubMed 24666408Lambiase 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.
PubMed 24357656Coroian 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.
PubMed 28947166Friedman 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.
PubMed 24885076
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Imaginary Resisted Exercise Versus Physical Resisted Exercise on Hand Grip Strength in Stroke Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04894773
- Acronym / sponsor ID
- REC/FSD/0234
- Conditions
- Stroke
- Keywords
- Stroke, Physical Resisted exercise, Imaginary Resisted exercise, Hand grip strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of our study is to make a comparison between the effectiveness of physical resistance exercise and imaginary resistance exercise in improving handgrip strength, dexterity, and eye-hand coordination among stroke patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imaginary Resisted Exercises | Experimental | Other: Imaginary Resistance ExercisesHandgrip 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. |
| Physical Resisted Exercises | Experimental | Other: Physical Resisted ExercisesHandgrip 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. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaginary Resistance ExercisesAlso: Rehabilitation following Imaginary Resistance ExercisesIn 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 | Imaginary Resisted Exercises |
| Physical Resisted ExercisesAlso: Rehabilitation following Physical Resisted ExercisesIn physical resistance exercises, resistive force is applied to the targeted region by using different and appropriate resistive objects. | Other | Physical Resisted Exercises |
Primary outcome
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- BackgroundAllen 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.
- Background: PubMed 21254080Amirjani 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.
- Background: PubMed 28183337Johansson 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.
- Background: PubMed 24666408Jones 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.
- Background: PubMed 24357656Lambiase 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.
- Background: PubMed 28947166Coroian 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.
- Background: PubMed 24885076Friedman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Kashif study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaginary Resistance Exercises and Physical Resisted Exercises in people with Stroke, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hydraulic Hand Dynamometer (time frame: 12th Week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04894773, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023; AzTrials last refreshed its copy on 26 Oct 2026.