Back to resultsMotor Coordination and Grip Strength of the Dominant and Non-dominant Hand and Wrist in Post-stroke Patients.
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
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring dominant hand, non-dominant hand, coordination, grip strength, stabilization, stroke
Eligibility Criteria
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;
Sites / Locations
- Military Institute of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
motor coordination and grip strength in dominant/non-dominant hand
Arm Description
Dominant and non-dominant hand motor coordination and grip strength were tested in the stable position of the trunk and the upper arm, in post-stroke patients (study group) and in healthy subjects (control group).
Outcomes
Primary Outcome Measures
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).
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).
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.
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.
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04889612
Brief Title
Motor Coordination and Grip Strength of the Dominant and Non-dominant Hand and Wrist in Post-stroke Patients.
Official Title
Analysis of the Influence of the Position of the Trunk and the Affected Upper Limb on Motor Coordination and Grip Strength of the Dominant and Non-dominant Hand and Wrist in Post-stroke Patients Compared to Healthy Controls.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
October 10, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anna Olczak
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 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
dominant hand, non-dominant hand, coordination, grip strength, stabilization, stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
motor coordination and grip strength in dominant/non-dominant hand
Arm Type
Experimental
Arm Description
Dominant and non-dominant hand motor coordination and grip strength were tested in the stable position of the trunk and the upper arm, in post-stroke patients (study group) and in healthy subjects (control group).
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 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.
Intervention Type
Procedure
Intervention Name(s)
hand motor coordination in a supine position
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of wrist movement (flexion to extension), cycles#/sec
Description
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).
Time Frame
up to 1 week
Title
Frequency of 1st, 2nd, 3rd, 4th, 5th finger movement (flexion to extension), cycles#/sec
Description
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).
Time Frame
up to 1 week
Title
Wrist maximum range of motion (ROM) [mm]
Description
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.
Time Frame
up to 1 week
Title
1st, 2nd, 3rd, 4th, 5th finger maximum range of motion (ROM), [mm]
Description
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.
Time Frame
up to 1 week
Title
Assessment of the grip strength
Description
Grip strength, kg (a manual electronic dynamometer (EH 101) was used for grip strength measurement (error of measurement, 0.5 kg/lb)
Time Frame
up to 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
91 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Olczak, PhD
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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Motor Coordination and Grip Strength of the Dominant and Non-dominant Hand and Wrist in Post-stroke Patients.
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