NCT04894773

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

May 19, 2021

Last Update Submit

August 31, 2023

Conditions

Keywords

StrokePhysical Resisted exerciseImaginary Resisted exerciseHand grip strength

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

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.

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.

Other: Physical Resisted Exercises

Interventions

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.

Also known as: Rehabilitation following Imaginary Resistance Exercises
Imaginary Resisted Exercises

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

Also known as: Rehabilitation following Physical Resisted Exercises
Physical Resisted Exercises

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ripah International University

Faisalabad, Punjab Province, 38000, Pakistan

Location

Related 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.

    BACKGROUND
  • 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.

    PMID: 21254080BACKGROUND
  • 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.

    PMID: 28183337BACKGROUND
  • 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.

    PMID: 24666408BACKGROUND
  • 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.

    PMID: 24357656BACKGROUND
  • 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.

    PMID: 28947166BACKGROUND
  • 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.

    PMID: 24885076BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Muhammad Kashif

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Our study will be single-blinded, outcome assessor-blinded. The assessor will be blinded to avoid being biased during the outcome assessment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 20, 2021

Study Start

March 1, 2021

Primary Completion

August 30, 2021

Study Completion

September 1, 2021

Last Updated

September 5, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations