StrokeNCT04782141
Positioning the Trunk and Upper Limb to Improve the Coordination of the Hand Movement After Stroke
A study testing hand motor coordination in a sitting positin, hand motor coordination in a supine position with the upper extremity positioned perpendicularly to the trunk and hand motor coordination in a supine position with adduction in the humeral joint, elbow flexion in the intermediate position in people with Stroke, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
Trial summary
This study investigated how torso and shoulder positioning can help restore coordinated hand movements in stroke patients. Read more about this study
- Who is it for?
- Ages 20 to 87 years
- Conditions the study is for
- Stroke
- What is being tested?
- hand motor coordination in a sitting positin, hand motor coordination in a supine position with the upper extremity positioned perpendicularly to the trunk and hand motor coordination in a supine position with adduction in the humeral joint, elbow flexion in the intermediate position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 1 sitePoland
- Study dates
- 5 Aug 2019to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 87 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Positioning the Trunk and Upper Limb to Improve the Coordination of the Wrist and Fingers After Stroke
This study investigated how torso and shoulder positioning can help restore coordinated hand movements in stroke patients.
Read the 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.
- Conditions
- Stroke
- Being tested
- 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
- Keywords
- stroke, motor coordination, grip strength, rehabiliatation, stabilization, positioning
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand motor coordination in a sitting positinProcedure or surgery
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 trunkProcedure or surgery
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 positionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Positioning the trunk and upper limb to improve the coordination the hand. | Experimental | The study investigated the effects of the trunk and upper limb positioning on improving wrist and hand coordination. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of passive movement of the wrist
The Hand Tutor allows measurements of the range of passive movement of the wrist (in mm).
Measured: up to 10 weeks
Range of active movement of the wrist
The Hand Tutor allows measurements of the range of active movement of the wrist (in mm)
Measured: up to 10 week
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)
Measured: up to 10 weeks
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.
Measured: up to 10 weeks
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.
Measured: up to 10 weeks
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).
Measured: up to 10 weeks
Range of passive movement of the fingers
The Hand Tutor allows measurements of the passive movement of the fingers (in mm)
Measured: up to 10 weeks
Range of active movement of the fingers
The Hand Tutor allows measurements of the active movement of the fingers (in mm)
Measured: up to 10 weeks
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.
Measured: up to 10 weeks
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.
Measured: up to 10 weeks
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.
Measured: up to 10 weeks
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)
Measured: up to 10 weeks
Assessment of the grip strength
Grip strength, kg (a manusl electronic dynamometr (EH 101) was used for grip strength
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start5 Aug 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Olczak, Military Institute od Medicine National Research Institute
- Investigators
- Anna Olczak, MD, Principal investigator, Rehabilitation Clinic, Military Institute of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782141
- Sponsor's protocol ID
- 5/KRN/2020
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positioning the Trunk and Upper Limb to Improve the Coordination of the Wrist and Fingers After Stroke
- ClinicalTrials.gov ID
- NCT04782141
- Acronym / sponsor ID
- 5/KRN/2020
- Conditions
- Stroke
- Keywords
- stroke, motor coordination, grip strength, rehabiliatation, stabilization, positioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positioning the trunk and upper limb to improve the coordination the hand. | Experimental | 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 positionThe study investigated the effects of the trunk and upper limb positioning on improving wrist and hand coordination. |
Who may qualify
- Ages
- 20 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hand motor coordination in a sitting positinThe 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. | Procedure or surgery | Positioning the trunk and upper limb to improve the coordination the hand. |
| hand motor coordination in a supine position with the upper extremity positioned perpendicularly to the trunkmotor 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. | Procedure or surgery | Positioning the trunk and upper limb to improve the coordination the hand. |
| hand motor coordination in a supine position with adduction in the humeral joint, elbow flexion in the intermediate positionIn 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. | Procedure or surgery | Positioning the trunk and upper limb to improve the coordination the hand. |
Primary outcome
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).
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)
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)
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.
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.
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).
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)
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)
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.
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.
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.
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Olczak, MD principal investigator
Rehabilitation Clinic, Military Institute of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hand motor coordination in a sitting positin, hand motor coordination in a supine position with the upper extremity positioned perpendicularly to the trunk and hand motor coordination in a supine position with adduction in the humeral joint, elbow flexion in the intermediate position in people with Stroke, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of passive movement of the wrist (time frame: up to 10 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.