- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04889612
Motor Coordination and Grip Strength of the Dominant and Non-dominant Hand and Wrist in Post-stroke Patients.
Analysis of the Influence of the Position of the Trunk and the Affected Upper Limb on Motor Coordination and Grip Strength of the Dominant and Non-dominant Hand and Wrist in Post-stroke Patients Compared to Healthy Controls.
Study Overview
Status
Conditions
Detailed Description
The examination of the dominant and non-dominant paretic hand consisted of two motor tasks, carried out in two different starting positions: sitting and lying down (supine).
During the first examination, the subject sat on the therapeutic table (without back support), feet resting on the floor. The upper limb was examined in adduction of the humeral joint, with the elbow bent in the intermediate position between pronation and supination of the forearm, with free wrist and the hand.
In the supine position, the affected upper limb was stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position, wrist and hand free). The Hand Tutor device and an electronic hand dynamometer were used for the measurements. In each of the starting positions, after putting the glove on (using the Hand Tutor Device), the subject was asked to make moves as quickly and in as full a range as possible. Finally, the measurement of grip strength with a dynamometer was performed in both analyzed starting positions, after completing the range of motion and frequency tests.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Masovian District
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Warsaw, Masovian District, Poland, 04-141
- Military Institute of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Stroke Inclusion Criteria:1) participants with ischemic stroke; 2) participants with hemiparesis after 5 to 7 week after stroke; 3) participants with stable trunk (the Trunk Control Test 70-100 points); 4) participants who were in a functional state allowing movements of the upper extremity (FMA-UE 40-66 motor function points); 5) muscle tension (MAS 0 -1+); 6) no severe deficits in communication, memory, or understanding what can impede proper measurement performance; Stroke Exclusion Criteria:1) stroke up to two weeks after the episode, 2) acute polyneuropathy and damage to peripheral nerves, 3) lack of trunk stability, 4) no wrist and hand movement, 5) muscle tension (˃2 MAS), 6) high or very low blood pressure, 7) dizziness, a malaise of the respondents.
Healthy Inclusion Criteria - 1) the control group consisted of participants free from the upper extremity motor coordination disorders; Healthy Exclusion Criteria: 1) participants with a history of neurologic or musculoskeletal disorders such as carpal tunnel syndrome, tendonitis, stroke, head injury, or other conditions that could affect their ability to active movement and grip hand; 2) with severe deficits in communication, memory, or understanding what can impede proper measurement performance;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: motor coordination and grip strength in dominant/non-dominant hand
Dominant and non-dominant hand motor coordination and grip strength were tested in the stable position of the trunk and the upper arm, in post-stroke patients (study group) and in healthy subjects (control group).
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The subject sat on the therapeutic table (without back support), feet resting on the floor.
The upper limb was to be examined in adduction of the humeral joint, with the elbow bent in the intermediate position between pronation and supination of the forearm, with free wrist and the hand.
After putting the glove on, the subject was asked to make moves as quickly and in as full a range as possible.
Finally, the measurement of grip strength with a dynamometer was performed.
In the supine position, the upper limb was stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position, wrist and hand free).
After putting the Hand Tutor glove on, the subject was asked to make moves as quickly and in as full a range as possible.
Finally, the measurement of grip strength with a dynamometer was performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of wrist movement (flexion to extension), cycles#/sec
Time Frame: up to 1 week
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The Hand Tutor allows measurements the speed or frequency (i.e., the number of cycles per second, where one cycle represents the movement from flexion to contraction).
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up to 1 week
|
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Frequency of 1st, 2nd, 3rd, 4th, 5th finger movement (flexion to extension), cycles#/sec
Time Frame: up to 1 week
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The Hand Tutor allows measurements the speed or frequency (i.e., the number of cycles per second, where one cycle represents the movement from flexion to contraction).
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up to 1 week
|
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Wrist maximum range of motion (ROM) [mm]
Time Frame: up to 1 week
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The Hand Tutor allows measurements of the maximum range of motion (ROM). ROM is a sum of the wrist flexion or extension angles (mm). ROM is a sum of all the finger flexion or extension angles (i.e. at the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints), mm. |
up to 1 week
|
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1st, 2nd, 3rd, 4th, 5th finger maximum range of motion (ROM), [mm]
Time Frame: up to 1 week
|
The Hand Tutor allows measurements of the maximum range of motion (ROM). ROM is a sum of the wrist flexion or extension angles (mm). ROM is a sum of all the finger flexion or extension angles (i.e. at the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints), mm. |
up to 1 week
|
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Assessment of the grip strength
Time Frame: up to 1 week
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Grip strength, kg (a manual electronic dynamometer (EH 101) was used for grip strength measurement (error of measurement, 0.5 kg/lb)
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up to 1 week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Olczak, PhD, Rehabilitation Clinic, Military Institute of Medicine
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
- 7/KRN/2019
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
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