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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05008302
Other study ID # 2/KRN/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 10, 2019
Est. completion date December 15, 2019

Study information

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

Clinical Trial Summary

The aim of the study was to analyze the importance of the position of the body and the examined upper limb on the parameters of movement coordination and hand grip strength in various age groups of people after a stroke and healthy individuals.


Description:

The aim of this experiment was to analyze the parameters of motor coordination and handshake strength in stroke patients and healthy volunteers in various age groups and selected torso and upper limb positions. Both patients and healthy volunteers were prospectively divided into three age groups: 18-45, 46-60 and 61 and above. Thus, the maximum range of motion (ROM), frequency of wrist and finger movements, and grip strength (dependent variables) were valued in three age groups and different starting positions (independent variables). The Hand Tutor device (MediTouch, Israel) and the electronic manual dynamometer EH 101 (Camry, China) for grip strength measurement (error of measurement, 0.5 kg/lb) were used. The Hand Tutor allows measurements of the frequency of movement (i.e., the number of cycles per second, where one cycle represents the movement from flexion to contraction) and the maximum range of movement, which is automatically measured during the frequency test, were performed over time 10 seconds (sensitivity: 0,05 [mm] of wrist and fingers Ext./Flex), the frequency of movement (motion capture speed: up to 1 [m/sec]). The test 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 to be examined in adduction, with the elbow bent in the intermediate position between pronation and supination of the forearm. 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). In each of the starting positions, 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 both analyzed starting positions, after completing the range of motion and speed or frequency tests. The upper extremity tested in stroke patients was the paretic extremity. In healthy subjects, the dominant hand was tested.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 15, 2019
Est. primary completion date December 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 89 Years
Eligibility Inclusion Criteria:1) patients with ischemic stroke; 2) Trunk Control Test 70-100 points; 3) subjects who were in a state allowing movements of the upper extremity (FMA-UE 40-66 motor function points); 4) muscle tension (MAS 0 -1+); 5) no severe deficits in communication, memory, or understanding; 6) at least 18 years of age. - Exclusion Criteria:1) stroke up to four weeks after the episode, 2) another neurological disease entity 3) lack of trunk stability, 4) no wrist and hand movement, 5) muscle tension (?2 MAS), 6) high or very low blood pressure, 7) severe deficits in communication, memory, or understanding; dizziness, the malaise of the respondents. Control group inclusion criteria: 1) the control group consisted of healthy subjects, free from the upper extremity motor coordination disorders; 2) at least 18 years of age. Control group exclusion criteria: 1) 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) severe deficits in communication, memory, or understanding. -

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
hand motor coordination in a sitting positin
Before each test, the patient was instructed on how the exercise should be done. The test 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 to be examined in adduction, with the elbow bent in the intermediate position between pronation and supination of the forearm. 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).

Locations

Country Name City State
Poland Anna Olczak Warszawa 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 Maximum range of movement of the wrist [mm] Hand Tutor allows measurements of the maximum range of motion (ROM). up to 1 week
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 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 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). 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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