StrokeNCT04771533
Passive Stabilization of the Trunk and Upper Arm in Hand Rehabilitation After Stroke
A study testing hand motor coordination in a sitting position 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 correlations between muscle tone, stabilization of the trunk and the upper extremity, and parameters of hand/wrist motor coordination in post-stroke patients and neurologically healthy subjects with lower back pain. Read more about this study
- Who is it for?
- Ages 44 to 83 years
- Conditions the study is for
- Stroke
- What is being tested?
- hand motor coordination in a sitting position 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
- 66 participants
- Where
- 1 sitePoland
- Study dates
- 5 Aug 2019to 10 Sep 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 44 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with hemiparesis 5 to 7 week after stroke;
- no severe deficits in communication, memory, or understanding what can impede proper measurement performance;
- at least 40 years of age.
- no upper extremity motor coordination disorders
- at least 40 years of age
Who cannot join
- stroke up to five weeks after the episode;
- epilepsy;
- lack of trunk stability;
- no wrist and hand movement;
- high or very low blood pressure;
- dizziness;
Show all 13Show fewer
- malaise.
- Control Group
- history of neurologic or musculoskeletal disorders such as carpal tunnel syndrome, tendonitis, stroke, head injury, or other conditions that could affect the ability for active movement and handgrip;
- severe deficits in communication, memory, or understanding which could impede proper measurement performance;
- high or very low blood pressure;
- dizziness;
- malaise
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to assess correlations between muscle tone, stabilization of the trunk and the upper extremity, and parameters of hand/wrist motor coordination in post-stroke patients and neurologically healthy subjects with lower back pain.
Read the detailed description
A Luna electromyography (EMG) (EGZOTech) was used to measure muscle tension, and 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, as well as the speed/frequency of movement. The Hand Tutor glove was worn on the hand of the directly affected side in stroke patients and on the dominant extremity in patients with pain syndrome. Surface electrodes (single-use 55' and '40 mm; ECG Electrodes; limited liability company and limited partnership (Sorimex), Poland were affixed to the subject's body according to the SENIAM (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles) procedure on the transverse abdominal, multifidus, and supraspinal muscles (on the side directly affected in stroke patients, and on the dominant side in patients with back pain syndrome). Before each exercise, the subject was instructed on how the exercise should be done.
The examination 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 upper limb was stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position, wrist and hand free).
In each of the starting positions, after putting the glove on, the range of passive movement in the radial-carpal joint (flexion and extension) and fingers (global flexion and extension) was measured. Then the subject made active movement in the same order. Finally, 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.
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 (sitting or supine) 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 both positions (sitting or supine) after the range of motion and speed/frequency tests. The reaction of the examined multifidus, transverse abdominal, and supraspinatus muscles (tension values reported in microvolts (µV) was also assessed during each of the exercise tasks using the surface electrodes (i.e., during movement of the wrist and during movement of the fingers).
- Conditions
- Stroke
- Being tested
- hand motor coordination in a sitting position, hand motor coordination in a supine position
- Keywords
- stroke, core stability, muscle tone, hand coordination
- 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 positionProcedure 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 range of passive movement in the radial-carpal joint (flexion and extension) and fingers (global flexion and extension) was measured. Then the subject made active movement in the same order. Finally, 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 the hand free). After putting the glove on, the range of passive movement in the radial-carpal joint (flexion and extension) and fingers (global flexion and extension) was measured. Then the subject made active movement in the same order. Finally, 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 |
|---|---|---|
| Passive stabilization of the trunk and the upper extremity | Experimental | The intervention (passive stabilization of the trunk and the upper arm) was tested in post-stroke patients (study group) and in patients with back pain, but without neurological deficits (control group) Receives: Procedure: hand motor coordination in a sitting position; 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.
Range of passive movement of the wrist, mm 1st, 2nd, 3rd, 4th, 5th finger passive movement, mm
The Hand Tutor allows measurements of the range of passive movement (in mm).
Measured: up to 10 weeks
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 10 weeks
Assessment of the muscle tension
A Luna electromyography (EMG) (a rehabilitation-diagnostic robot developed by EGZOTech) was used to measure muscle tension. Surface electrodes (single-use 55' and '40 mm; ECG Electrode; limited liability company, limited partnership (Sorimex), Poland) were affixed to the subject's body according to the Surface Electromyography for the Non-Invasive Assessment of Muscles (SENIAM) procedure on the transverse abdominal, multifidus, and supraspinal muscles.
Measured: up to 10 weeks
Range of active movement of the wrist, mm 1st, 2nd, 3rd, 4th, 5th finger active movement, mm
The Hand Tutor allows measurements of the range of active movement (in mm).
Measured: up to 10 weeks
Wrist extension deficit, mm 1st, 2nd, 3rd, 4th, 5th finger extension deficit, mm
The Hand Tutor allows measurements of the extension deficit. The extension deficit refers to the difference between passive and active extension ROM.
Measured: up to 10 weeks
Wrist flexion deficit, mm 1st, 2nd, 3rd, 4th, 5th finger flexion deficit, mm
The Hand Tutor allows measurements of the flexion deficit. The flexion deficit refers to the difference between passive and active flexion ROM.
Measured: up to 10 weeks
Wrist maximum range of motion (ROM), 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.
Measured: up to 10 weeks
Frequency of wrist movement (flexion to extension), cycles#/sec 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 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start5 Aug 2019
- Primary completion10 Sep 2019
- Study completion10 Sep 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
- 66 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, MD, Principal investigator, Rehabilitation Clinic, Military Institute of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771533
- Sponsor's protocol ID
- 3/KRN/2019
- Status last verified
- Feb 2021
- First submitted
- 16 Feb 2021
- Last updated
- 2 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 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Stabilization of the Trunk and Upper Arm in Hand Rehabilitation After Stroke
- ClinicalTrials.gov ID
- NCT04771533
- Acronym / sponsor ID
- 3/KRN/2019
- Conditions
- Stroke
- Keywords
- stroke, core stability, muscle tone, hand coordination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Anna OlczakUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 25 Feb 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 correlations between muscle tone, stabilization of the trunk and the upper extremity, and parameters of hand/wrist motor coordination in post-stroke patients and neurologically healthy subjects with lower back pain.
Detailed description
A Luna electromyography (EMG) (EGZOTech) was used to measure muscle tension, and 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, as well as the speed/frequency of movement. The Hand Tutor glove was worn on the hand of the directly affected side in stroke patients and on the dominant extremity in patients with pain syndrome. Surface electrodes (single-use 55' and '40 mm; ECG Electrodes; limited liability company and limited partnership (Sorimex), Poland were affixed to the subject's body according to the SENIAM (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles) procedure on the transverse abdominal, multifidus, and supraspinal muscles (on the side directly affected in stroke patients, and on the dominant side in patients with back pain syndrome). Before each exercise, the subject was instructed on how the exercise should be done.
The examination 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 upper limb was stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position, wrist and hand free).
In each of the starting positions, after putting the glove on, the range of passive movement in the radial-carpal joint (flexion and extension) and fingers (global flexion and extension) was measured. Then the subject made active movement in the same order. Finally, 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.
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 (sitting or supine) 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 both positions (sitting or supine) after the range of motion and speed/frequency tests. The reaction of the examined multifidus, transverse abdominal, and supraspinatus muscles (tension values reported in microvolts (µV) was also assessed during each of the exercise tasks using the surface electrodes (i.e., during movement of the wrist and during movement of the fingers).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Passive stabilization of the trunk and the upper extremity | Experimental | Procedure: hand motor coordination in a sitting position, Procedure: hand motor coordination in a supine positionThe intervention (passive stabilization of the trunk and the upper arm) was tested in post-stroke patients (study group) and in patients with back pain, but without neurological deficits (control group) |
Who may qualify
- Ages
- 44 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with hemiparesis 5 to 7 week after stroke;
- no severe deficits in communication, memory, or understanding what can impede proper measurement performance;
- at least 40 years of age.
- no upper extremity motor coordination disorders
- at least 40 years of age
Key exclusion criteria (13 listed)
- stroke up to five weeks after the episode;
- epilepsy;
- lack of trunk stability;
- no wrist and hand movement;
- high or very low blood pressure;
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 positionThe 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 range of passive movement in the radial-carpal joint (flexion and extension) and fingers (global flexion and extension) was measured. Then the subject made active movement in the same order. Finally, 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 | Passive stabilization of the trunk and the upper extremity |
| 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 the hand free). After putting the glove on, the range of passive movement in the radial-carpal joint (flexion and extension) and fingers (global flexion and extension) was measured. Then the subject made active movement in the same order. Finally, 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 | Passive stabilization of the trunk and the upper extremity |
Primary outcome
Range of passive movement of the wrist, mm 1st, 2nd, 3rd, 4th, 5th finger passive movement, mm
Time frame: up to 10 weeks
The Hand Tutor allows measurements of the range of passive movement (in mm).
Assessment of the grip strength
Time frame: up to 10 weeks
Grip strength, kg (a manual electronic dynamometer (EH 101) was used for grip strength measurement (error of measurement, 0.5 kg/lb)
Assessment of the muscle tension
Time frame: up to 10 weeks
A Luna electromyography (EMG) (a rehabilitation-diagnostic robot developed by EGZOTech) was used to measure muscle tension. Surface electrodes (single-use 55' and '40 mm; ECG Electrode; limited liability company, limited partnership (Sorimex), Poland) were affixed to the subject's body according to the Surface Electromyography for the Non-Invasive Assessment of Muscles (SENIAM) procedure on the transverse abdominal, multifidus, and supraspinal muscles.
Range of active movement of the wrist, mm 1st, 2nd, 3rd, 4th, 5th finger active movement, mm
Time frame: up to 10 weeks
The Hand Tutor allows measurements of the range of active movement (in mm).
Wrist extension deficit, mm 1st, 2nd, 3rd, 4th, 5th finger extension deficit, mm
Time frame: up to 10 weeks
The Hand Tutor allows measurements of the extension deficit. The extension deficit refers to the difference between passive and active extension ROM.
Wrist flexion deficit, mm 1st, 2nd, 3rd, 4th, 5th finger flexion deficit, mm
Time frame: up to 10 weeks
The Hand Tutor allows measurements of the flexion deficit. The flexion deficit refers to the difference between passive and active flexion ROM.
Wrist maximum range of motion (ROM), mm 1st, 2nd, 3rd, 4th, 5th finger maximum range of motion (ROM), mm
Time frame: up to 10 weeks
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.
Frequency of wrist movement (flexion to extension), cycles#/sec Frequency of 1st, 2nd, 3rd, 4th, 5th finger movement (flexion to extension), cycles#/sec
Time frame: up to 10 weeks
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).
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 2 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 position 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?
The sponsor lists 5 inclusion and 13 exclusion criteria. 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 2 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, mm 1st, 2nd, 3rd, 4th, 5th finger passive movement, mm (time frame: up to 10 weeks). The study lists 8 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 2 Mar 2021.