Clinical trial NCT04782141: Positioning the Trunk and Upper Limb to Improve the Coordination of the Hand Movement After Stroke
Official title: Positioning the Trunk and Upper Limb to Improve the Coordination of the Wrist and Fingers After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
motor coordination
grip strength
rehabiliatation
stabilization
positioning
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 277
Sex: ALL
Minimum age (years): 20
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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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Primary outcomes:
measure: Range of passive movement of the wrist
timeFrame: up to 10 weeks
measure: Range of active movement of the wrist
timeFrame: up to 10 week
measure: Wrist extension deficit (mm). The extension deficit refers to the difference between passive and active ROM.
timeFrame: up to 10 weeks
measure: Wrist flexion deficit mm
timeFrame: up to 10 weeks
measure: Wrist maximum range of motion (ROM), mm
timeFrame: up to 10 weeks
measure: Frequency of wrist movement (flexion to extension), cycles#/sec
timeFrame: up to 10 weeks
measure: Range of passive movement of the fingers
timeFrame: up to 10 weeks
measure: Range of active movement of the fingers
timeFrame: up to 10 weeks
measure: Fingers extension deficit mm
timeFrame: up to 10 weeks
measure: Fingers flexion deficit mm
timeFrame: up to 10 weeks
measure: Fingers maximum range of motion (ROM), mm
timeFrame: up to 10 weeks
measure: Frequency of fingers movement (flexion to extension), cycles#/sec
timeFrame: up to 10 weeks
measure: Assessment of the grip strength
timeFrame: up to 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Military Institute of Medicine
state: Masovian District
Study officials:
affiliation: Rehabilitation Clinic, Military Institute of Medicine
name: Anna Olczak, MD
role: PRINCIPAL_INVESTIGATOR
References: