StrokeNCT05008302
Age and Body Position on Handgrip Strength and Movement Coordination of Upper Limb
A study testing hand motor coordination in a sitting positin in people with Stroke, run by Anna Olczak at 1 site in Poland.
Trial summary
The aim of the study was to analyze the importance of the position of the body and the examined upper limb on the parameters of movement coordination and hand grip strength in various age groups of people after a stroke and healthy individuals. Read more about this study
- Who is it for?
- Ages 22 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- hand motor coordination in a sitting positin
- 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
- 10 Apr 2019to 15 Dec 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 22 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria:1) patients with ischemic stroke; 2) Trunk Control Test 70-100 points; 3) subjects who were in a state allowing movements of the upper extremity (FMA-UE 40-66 motor function points); 4) muscle tension (MAS 0 -1+); 5) no severe deficits in communication, memory, or understanding; 6) at least 18 years of age.
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Exclusion Criteria:1) stroke up to four weeks after the episode, 2) another neurological disease entity 3) lack of trunk stability, 4) no wrist and hand movement, 5) muscle tension (˃2 MAS), 6) high or very low blood pressure, 7) severe deficits in communication, memory, or understanding; dizziness, the malaise of the respondents.
Control group inclusion criteria: 1) the control group consisted of healthy subjects, free from the upper extremity motor coordination disorders; 2) at least 18 years of age.
Control group exclusion criteria: 1) 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) severe deficits in communication, memory, or understanding.
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Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study was to analyze the importance of the position of the body and the examined upper limb on the parameters of movement coordination and hand grip strength in various age groups of people after a stroke and healthy individuals.
Read the detailed description
The aim of this experiment was to analyze the parameters of motor coordination and handshake strength in stroke patients and healthy volunteers in various age groups and selected torso and upper limb positions. Both patients and healthy volunteers were prospectively divided into three age groups: 18-45, 46-60 and 61 and above. Thus, the maximum range of motion (ROM), frequency of wrist and finger movements, and grip strength (dependent variables) were valued in three age groups and different starting positions (independent variables). The Hand Tutor device (MediTouch, Israel) and the electronic manual dynamometer EH 101 (Camry, China) for grip strength measurement (error of measurement, 0.5 kg/lb) were used.
The Hand Tutor allows measurements of the frequency of movement (i.e., the number of cycles per second, where one cycle represents the movement from flexion to contraction) and the maximum range of movement, which is automatically measured during the frequency test, were performed over time 10 seconds (sensitivity: 0,05 [mm] of wrist and fingers Ext./Flex), the frequency of movement (motion capture speed: up to 1 [m/sec]).
The test 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 to be 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 stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position).
In each of the starting positions, 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 in both analyzed starting positions, after completing the range of motion and speed or frequency tests. The upper extremity tested in stroke patients was the paretic extremity. In healthy subjects, the dominant hand was tested.
- Conditions
- Stroke
- Being tested
- hand motor coordination in a sitting positin
- Keywords
- stroke, age, grip strength, coordination movement, stabilization
- 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
Also called hand motor coordination in a supine position
Before each test, the patient was instructed on how the exercise should be done. The test 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 to be 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 stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position).
| Study group | Role | What they receive |
|---|---|---|
| To improve the coordination of the wrist and hand after stroke in three age groups. | Experimental | The test 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 to be 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 stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position). Receives: Procedure: hand motor coordination in a sitting positin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum range of movement of the wrist [mm]
Hand Tutor allows measurements of the maximum range of motion (ROM).
Measured: up to 1 week
Frequency of wrist movement (flexion to extension), cycles#/sec
The Hand Tutor allows measurements the speed or frequency (i.e., the number of cycles
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
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).
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 Aug 2021
- Study start10 Apr 2019
- Primary completion15 Dec 2019
- Study completion15 Dec 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, Military Institute of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008302
- Sponsor's protocol ID
- 2/KRN/2019
- Status last verified
- Aug 2021
- First submitted
- 10 Aug 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age and Body Position on Handgrip Strength and Movement Coordination of Upper Limb
- ClinicalTrials.gov ID
- NCT05008302
- Acronym / sponsor ID
- 2/KRN/2019
- Conditions
- Stroke
- Keywords
- stroke, age, grip strength, coordination movement, stabilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Anna OlczakUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 17 Aug 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.
The aim of the study was to analyze the importance of the position of the body and the examined upper limb on the parameters of movement coordination and hand grip strength in various age groups of people after a stroke and healthy individuals.
Detailed description
The aim of this experiment was to analyze the parameters of motor coordination and handshake strength in stroke patients and healthy volunteers in various age groups and selected torso and upper limb positions. Both patients and healthy volunteers were prospectively divided into three age groups: 18-45, 46-60 and 61 and above. Thus, the maximum range of motion (ROM), frequency of wrist and finger movements, and grip strength (dependent variables) were valued in three age groups and different starting positions (independent variables). The Hand Tutor device (MediTouch, Israel) and the electronic manual dynamometer EH 101 (Camry, China) for grip strength measurement (error of measurement, 0.5 kg/lb) were used.
The Hand Tutor allows measurements of the frequency of movement (i.e., the number of cycles per second, where one cycle represents the movement from flexion to contraction) and the maximum range of movement, which is automatically measured during the frequency test, were performed over time 10 seconds (sensitivity: 0,05 [mm] of wrist and fingers Ext./Flex), the frequency of movement (motion capture speed: up to 1 [m/sec]).
The test 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 to be 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 stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position).
In each of the starting positions, 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 in both analyzed starting positions, after completing the range of motion and speed or frequency tests. The upper extremity tested in stroke patients was the paretic extremity. In healthy subjects, the dominant hand was tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| To improve the coordination of the wrist and hand after stroke in three age groups. | Experimental | Procedure: hand motor coordination in a sitting positinThe test 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 to be 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 stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position). |
Who may qualify
- Ages
- 22 to 89 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 positinAlso: hand motor coordination in a supine positionBefore each test, the patient was instructed on how the exercise should be done. The test 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 to be 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 stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position). | Procedure or surgery | To improve the coordination of the wrist and hand after stroke in three age groups. |
Primary outcome
Maximum range of movement of the wrist [mm]
Time frame: up to 1 week
Hand Tutor allows measurements of the maximum range of motion (ROM).
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
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
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).
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 17 Aug 2021.
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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
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 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 17 Aug 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?
Maximum range of movement of the wrist [mm] (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 17 Aug 2021.