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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04894773
Other study ID # REC/FSD/0234
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date September 1, 2021

Study information

Verified date August 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 1, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers No
Gender All
Age group 50 Years to 74 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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 Exercises
In physical resistance exercises, resistive force is applied to the targeted region by using different and appropriate resistive objects.

Locations

Country Name City State
Pakistan Ripah International University Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12th Week
Primary 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 12th Week
Primary 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. 12th Week
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