Positioning the Trunk and Upper Limb to Improve the Coordination of the Hand Movement After Stroke

Stroke Clinical Trial

Official title:

Positioning the Trunk and Upper Limb to Improve the Coordination of the Wrist and Fingers After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782141
• Other study ID #: 5/KRN/2020
• Status: Completed
• Phase: N/A
• Start date: August 5, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: March 2021
• Source: Military Institute of Medicine, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigated how torso and shoulder positioning can help restore coordinated hand movements in stroke patients.

Description:

Stroke patients and healthy subjects were randomly divided into two different groups and tested in different positions. In study group 1, the exercise test consisted of two motor tasks carried out in two different starting positions: sitting and supine. During the first examination, the subject sat on the therapeutic table (without back support), feet resting on the floor (active stabilization of the trunk and shoulder). The upper limb was 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 held beside the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position; passive stabilization of the trunk and shoulder).

In study group 2, the exercise test again consisted of two motor tasks carried out in two different starting positions: supine with the upper extremity positioned perpendicularly to the trunk (passive stabilization of the trunk, active stabilization of the shoulder), and supine with the upper limb held beside the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position; passive stabilization of the trunk and shoulder).

A manual electronic dynamometer (EH 101) was used for grip strength measurement (error of measurement, 0.5 kg/lb). A Hand Tutor device (composed of a safe and comfortable glove equipped with position and motion sensors, and the Medi Tutor(TM) software) was used to measure the range of passive and active movement (error of measurement, 5 - 10 mm), as well as the speed/frequency of movement (error of measurement, 0,5 cycle/sec.).

First, the range of passive movement in the radial-carpal joint (flexion and extension) and fingers (global flexion and extension) was measured in each position using the Hand Tutor Device. Then the subject made active movements in the same order. Finally, the subject was asked to make moves as quickly and in as full a range as possible. The measurement of grip strength with a dynamometer was performed in each position after the range of motion and speed/frequency tests.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 87 Years

Eligibility

Study Group Inclusion Criteria:1) patients with hemiparesis after 5 to 7 weeks after stroke; 2) no severe deficits in communication, memory, or understanding what can impede proper measurement performance; 3) at least 20 years of age.

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Exclusion Criteria: 1) stroke up to 5 weeks after the episode; 2) epilepsy; 3) lack of trunk stability; 4) no wrist and hand movement; 5) high very low blood pressure; 6) dizziness; 7) malaise

Control Group

Inclusion Criteria: 1) the control group consisted of subjects free from the upper extremity motor coordination disorders; 2) at least 20 years of age.

Exclusion Criteria: 1) 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 handgrip; 2) severe deficits in communication, memory, or understanding what can impede proper measurement performance; 3) high very low blood pressure; 4) dizziness; 5) malaise

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Related Conditions & MeSH terms

• Stroke

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 examined in adduction, with the elbow bent in the intermediate position between pronation and supination of the forearm. Wrist and a hand free from stabilization.
• hand motor coordination in a supine position with the upper extremity positioned perpendicularly to the trunk
motor tasks carried out in starting positions: supine with the upper extremity positioned perpendicularly to the trunk; the upper limb in adduction and flexion in the humeral joint, elbow extension, forearm in the intermediate position; elbow, wrist, hand free from stabilization.
• hand motor coordination in a supine position with adduction in the humeral joint, elbow flexion in the intermediate position
In the supine position, the upper limb was held beside the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position between pronation and supination of the forearm. Wrist and a hand free from stabilization.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Military Institute of Medicine, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of passive movement of the wrist	The Hand Tutor allows measurements of the range of passive movement of the wrist (in mm).	up to 10 weeks
Primary	Range of active movement of the wrist	The Hand Tutor allows measurements of the range of active movement of the wrist (in mm)	up to 10 week
Primary	Wrist extension deficit (mm). The extension deficit refers to the difference between passive and active ROM.	The Hand Tutor allows measurements of the extension deficit (in mm)	up to 10 weeks
Primary	Wrist flexion deficit mm	The Hand Tutor allows measurements of the flexion deficit (in mm). The flexion deficit refers to the difference between passive and active ROM.	up to 10 weeks
Primary	Wrist maximum range of motion (ROM), mm	The Hand Tutor allows measurements of the maximum range of motion (ROM) (in mm), from flexion to extension.	up to 10 weeks
Primary	Frequency of wrist movement (flexion to extension), cycles#/sec	The Hand Tutor allows measurements of the speed or frequency (i.e., the number of cycles per sec).	up to 10 weeks
Primary	Range of passive movement of the fingers	The Hand Tutor allows measurements of the passive movement of the fingers (in mm)	up to 10 weeks
Primary	Range of active movement of the fingers	The Hand Tutor allows measurements of the active movement of the fingers (in mm)	up to 10 weeks
Primary	Fingers extension deficit mm	The Hand Tutor allows measurements of the extension deficit (in mm). The extension deficit refers to the difference between passive and active ROM.	up to 10 weeks
Primary	Fingers flexion deficit mm	The Hand Tutor allows measurements of the flexion deficit (in mm). The flexion deficit refers to the difference between passive and active ROM.	up to 10 weeks
Primary	Fingers maximum range of motion (ROM), mm	The Hand Tutor allows measurements of the maximum range of motion (ROM) (in mm), from flexion to extension of each finger.	up to 10 weeks
Primary	Frequency of fingers movement (flexion to extension), cycles#/sec	The Hand Tutor allows measurements of the speed or frequency (i.e., the number of cycles per sec)	up to 10 weeks
Primary	Assessment of the grip strength	Grip strength, kg (a manusl electronic dynamometr (EH 101) was used for grip strength	up to 10 weeks