- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04782141
Positioning the Trunk and Upper Limb to Improve the Coordination of the Hand Movement After Stroke
Positioning the Trunk and Upper Limb to Improve the Coordination of the Wrist and Fingers After Stroke
Study Overview
Status
Conditions
Intervention / Treatment
- Procedure: hand motor coordination in a sitting positin
- Procedure: hand motor coordination in a supine position with the upper extremity positioned perpendicularly to the trunk
- Procedure: hand motor coordination in a supine position with adduction in the humeral joint, elbow flexion in the intermediate position
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Masovian District
-
Warsaw, Masovian District, Poland, 04-141
- Military Institute of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Positioning the trunk and upper limb to improve the coordination the hand.
The study investigated the effects of the trunk and upper limb positioning on improving wrist and hand coordination.
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of passive movement of the wrist
Time Frame: up to 10 weeks
|
The Hand Tutor allows measurements of the range of passive movement of the wrist (in mm).
|
up to 10 weeks
|
Range of active movement of the wrist
Time Frame: up to 10 week
|
The Hand Tutor allows measurements of the range of active movement of the wrist (in mm)
|
up to 10 week
|
Wrist extension deficit (mm). The extension deficit refers to the difference between passive and active ROM.
Time Frame: up to 10 weeks
|
The Hand Tutor allows measurements of the extension deficit (in mm)
|
up to 10 weeks
|
Wrist flexion deficit mm
Time Frame: up to 10 weeks
|
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
|
Wrist maximum range of motion (ROM), mm
Time Frame: up to 10 weeks
|
The Hand Tutor allows measurements of the maximum range of motion (ROM) (in mm), from flexion to extension.
|
up to 10 weeks
|
Frequency of wrist movement (flexion to extension), cycles#/sec
Time Frame: up to 10 weeks
|
The Hand Tutor allows measurements of the speed or frequency (i.e., the number of cycles per sec).
|
up to 10 weeks
|
Range of passive movement of the fingers
Time Frame: up to 10 weeks
|
The Hand Tutor allows measurements of the passive movement of the fingers (in mm)
|
up to 10 weeks
|
Range of active movement of the fingers
Time Frame: up to 10 weeks
|
The Hand Tutor allows measurements of the active movement of the fingers (in mm)
|
up to 10 weeks
|
Fingers extension deficit mm
Time Frame: up to 10 weeks
|
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
|
Fingers flexion deficit mm
Time Frame: up to 10 weeks
|
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
|
Fingers maximum range of motion (ROM), mm
Time Frame: up to 10 weeks
|
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
|
Frequency of fingers movement (flexion to extension), cycles#/sec
Time Frame: up to 10 weeks
|
The Hand Tutor allows measurements of the speed or frequency (i.e., the number of cycles per sec)
|
up to 10 weeks
|
Assessment of the grip strength
Time Frame: up to 10 weeks
|
Grip strength, kg (a manusl electronic dynamometr (EH 101) was used for grip strength
|
up to 10 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5/KRN/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on hand motor coordination in a sitting positin
-
Anna OlczakCompleted
-
Anna OlczakCompleted
-
Anna OlczakCompleted
-
Anna OlczakCompletedStroke, IschemicPoland
-
Anne-Violette BruynnelUniversity Hospital, GenevaCompleted
-
Anna OlczakCompleted
-
Hospices Civils de LyonRecruiting
-
Hopital FochCompletedPostoperative Oxygen TherapyFrance
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Zeynep YurdakulUnknown