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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04889612
Other study ID # 7/KRN/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 5, 2019
Est. completion date October 10, 2019

Study information

Verified date May 2021
Source Military Institute of Medicine, Poland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to assess how stabilization of the trunk and the upper extremity can change the parameters of hand/wrist motor coordination and grip strength in dominant and non-dominant paretic upper limb, in post-stroke patients and neurologically healthy subjects.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date October 10, 2019
Est. primary completion date October 10, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 91 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
hand motor coordination in a sitting positin
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.
hand motor coordination in a supine position
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.

Locations

Country Name City State
Poland Military Institute of Medicine Warsaw Masovian District

Sponsors (1)

Lead Sponsor Collaborator
Anna Olczak

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of wrist movement (flexion to extension), cycles#/sec 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). up to 1 week
Primary Frequency of 1st, 2nd, 3rd, 4th, 5th finger movement (flexion to extension), cycles#/sec 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). up to 1 week
Primary Wrist maximum range of motion (ROM) [mm] 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
Primary 1st, 2nd, 3rd, 4th, 5th finger maximum range of motion (ROM), [mm] 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
Primary Assessment of the grip strength Grip strength, kg (a manual electronic dynamometer (EH 101) was used for grip strength measurement (error of measurement, 0.5 kg/lb) up to 1 week
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