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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
hand motor coordination in a sitting positin
hand motor coordination in a supine position with the upper extremity positioned perpendicularly to the trunk
hand motor coordination in a supine position with adduction in the humeral joint, elbow flexion in the intermediate position
Sponsored by
Military Institute od Medicine National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, motor coordination, grip strength, rehabiliatation, stabilization, positioning

Eligibility Criteria

20 Years - 87 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • Military Institute of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Positioning the trunk and upper limb to improve the coordination the hand.

Arm Description

The study investigated the effects of the trunk and upper limb positioning on improving wrist and hand coordination.

Outcomes

Primary Outcome Measures

Range of passive movement of the wrist
The Hand Tutor allows measurements of the range of passive movement of the wrist (in mm).
Range of active movement of the wrist
The Hand Tutor allows measurements of the range of active movement of the wrist (in mm)
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)
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.
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.
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).
Range of passive movement of the fingers
The Hand Tutor allows measurements of the passive movement of the fingers (in mm)
Range of active movement of the fingers
The Hand Tutor allows measurements of the active movement of the fingers (in mm)
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.
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.
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.
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)
Assessment of the grip strength
Grip strength, kg (a manusl electronic dynamometr (EH 101) was used for grip strength

Secondary Outcome Measures

Full Information

First Posted
March 1, 2021
Last Updated
March 3, 2021
Sponsor
Military Institute od Medicine National Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04782141
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Military Institute od Medicine National Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, motor coordination, grip strength, rehabiliatation, stabilization, positioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
277 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positioning the trunk and upper limb to improve the coordination the hand.
Arm Type
Experimental
Arm Description
The study investigated the effects of the trunk and upper limb positioning on improving wrist and hand coordination.
Intervention Type
Procedure
Intervention Name(s)
hand motor coordination in a sitting positin
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
hand motor coordination in a supine position with the upper extremity positioned perpendicularly to the trunk
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
hand motor coordination in a supine position with adduction in the humeral joint, elbow flexion in the intermediate position
Intervention Description
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.
Primary Outcome Measure Information:
Title
Range of passive movement of the wrist
Description
The Hand Tutor allows measurements of the range of passive movement of the wrist (in mm).
Time Frame
up to 10 weeks
Title
Range of active movement of the wrist
Description
The Hand Tutor allows measurements of the range of active movement of the wrist (in mm)
Time Frame
up to 10 week
Title
Wrist extension deficit (mm). The extension deficit refers to the difference between passive and active ROM.
Description
The Hand Tutor allows measurements of the extension deficit (in mm)
Time Frame
up to 10 weeks
Title
Wrist flexion deficit mm
Description
The Hand Tutor allows measurements of the flexion deficit (in mm). The flexion deficit refers to the difference between passive and active ROM.
Time Frame
up to 10 weeks
Title
Wrist maximum range of motion (ROM), mm
Description
The Hand Tutor allows measurements of the maximum range of motion (ROM) (in mm), from flexion to extension.
Time Frame
up to 10 weeks
Title
Frequency of wrist movement (flexion to extension), cycles#/sec
Description
The Hand Tutor allows measurements of the speed or frequency (i.e., the number of cycles per sec).
Time Frame
up to 10 weeks
Title
Range of passive movement of the fingers
Description
The Hand Tutor allows measurements of the passive movement of the fingers (in mm)
Time Frame
up to 10 weeks
Title
Range of active movement of the fingers
Description
The Hand Tutor allows measurements of the active movement of the fingers (in mm)
Time Frame
up to 10 weeks
Title
Fingers extension deficit mm
Description
The Hand Tutor allows measurements of the extension deficit (in mm). The extension deficit refers to the difference between passive and active ROM.
Time Frame
up to 10 weeks
Title
Fingers flexion deficit mm
Description
The Hand Tutor allows measurements of the flexion deficit (in mm). The flexion deficit refers to the difference between passive and active ROM.
Time Frame
up to 10 weeks
Title
Fingers maximum range of motion (ROM), mm
Description
The Hand Tutor allows measurements of the maximum range of motion (ROM) (in mm), from flexion to extension of each finger.
Time Frame
up to 10 weeks
Title
Frequency of fingers movement (flexion to extension), cycles#/sec
Description
The Hand Tutor allows measurements of the speed or frequency (i.e., the number of cycles per sec)
Time Frame
up to 10 weeks
Title
Assessment of the grip strength
Description
Grip strength, kg (a manusl electronic dynamometr (EH 101) was used for grip strength
Time Frame
up to 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
87 Years
Accepts Healthy Volunteers
No
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. - 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Olczak, MD
Organizational Affiliation
Rehabilitation Clinic, Military Institute of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Military Institute of Medicine
City
Warsaw
State/Province
Masovian District
ZIP/Postal Code
04-141
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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