StrokeNCT04889612
Motor Coordination and Grip Strength of the Dominant and Non-dominant Hand and Wrist in Post-stroke Patients.
A study testing hand motor coordination in a sitting positin and hand motor coordination in a supine position in people with Stroke, run by Anna Olczak at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 91 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- hand motor coordination in a sitting positin and hand motor coordination in a supine position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 5 Aug 2019to 10 Oct 2019
- 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 91 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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;
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- hand motor coordination in a sitting positin, hand motor coordination in a supine position
- Keywords
- dominant hand, non-dominant hand, coordination, grip strength, stabilization, stroke
- 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 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.
hand motor coordination in a supine positionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| motor coordination and grip strength in dominant/non-dominant hand | Experimental | 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). Receives: Procedure: hand motor coordination in a sitting positin; Procedure: hand motor coordination in a supine position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 1 week
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).
Measured: up to 1 week
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.
Measured: up to 1 week
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.
Measured: up to 1 week
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)
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start5 Aug 2019
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Olczak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Olczak, Military Institute od Medicine National Research Institute
- Investigators
- Anna Olczak, PhD, Principal investigator, Rehabilitation Clinic, Military Institute of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889612
- Sponsor's protocol ID
- 7/KRN/2019
- Status last verified
- May 2021
- First submitted
- 11 May 2021
- Last updated
- 19 May 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 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04889612
- Acronym / sponsor ID
- 7/KRN/2019
- Conditions
- Stroke
- Keywords
- dominant hand, non-dominant hand, coordination, grip strength, stabilization, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Anna OlczakUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 17 May 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| motor coordination and grip strength in dominant/non-dominant hand | Experimental | Procedure: hand motor coordination in a sitting positin, Procedure: hand motor coordination in a supine positionDominant 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). |
Who may qualify
- Ages
- 20 to 91 years
- Sex
- All
- Healthy volunteers
- 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 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. | Procedure or surgery | motor coordination and grip strength in dominant/non-dominant hand |
| hand motor coordination in a supine positionIn 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. | Procedure or surgery | motor coordination and grip strength in dominant/non-dominant hand |
Primary outcome
Frequency of wrist movement (flexion to extension), cycles#/sec
Time frame: up to 1 week
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
Time frame: up to 1 week
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]
Time frame: up to 1 week
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]
Time frame: up to 1 week
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
Time frame: up to 1 week
Grip strength, kg (a manual electronic dynamometer (EH 101) was used for grip strength measurement (error of measurement, 0.5 kg/lb)
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 19 May 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, PhD 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 and hand motor coordination in a supine position in people with Stroke, run by Anna Olczak 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 19 May 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?
Frequency of wrist movement (flexion to extension), cycles#/sec (time frame: up to 1 week). The study lists 5 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 19 May 2021.