Stroke, IschemicNCT04825405
The Use of the Tip Stim Glove Device to Achieve Coordinated Movement of the Human Hand
A study testing hand motor coordination in a sitting position after use TipStim Glove in people with Stroke, Ischemic, run by Anna Olczak at 1 site in Poland.
Trial summary
The study was to evaluate the use of the Tip Stim device to achieve coordinated movement and grip force in stroke patients under conditions of active and passive stabilization of the trunk. Read more about this study
- Who is it for?
- Ages 42 to 89 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- hand motor coordination in a sitting position after use TipStim Glove
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 sitePoland
- Study dates
- 10 Jul 2019to 14 Feb 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 42 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 40 years of age; 4) maximum 89 years of age.
-
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) hypersensitivity to electrical stimulation, 6) metal implants in the hand, cardiac dysfunction, epilepsy, 7) decorations on the fingers, 8) high or very low blood pressure, 9) dizziness , malaise of the respondents.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of the Tested Position and the Use of the TipStim Glove Device on the Improvement of the Hand Motor Coordination After Stroke
The study was to evaluate the use of the Tip Stim device to achieve coordinated movement and grip force in stroke patients under conditions of active and passive stabilization of the trunk.
Read the detailed description
To test the effectiveness of the Tip Stim device, each patient received (alternating) both the experimental and control treatments in a specific sequence to assess the coordination of human hand movement and the grip strength. The first therapy with the use of Tip Stim parameters (Ratio current time to pause time: 2 sec :5 sec; Ramp (rise time impulse): 0,3 sec; Frequency: 20 Hz; Pulse width: 300 µs). Another session (putting on the glove without setting any parameters) took place after a week (time to mute the effects of the intervention). The duration of each therapy session is 60 minutes. After the first therapeutic session and after a week, the parameters of movement coordination and hand grip were examined. The study of motor coordination and grip strength was performed in two different starting positions: sitting (no stabilization) (fig. 1) and lying (with stabilization) (fig. 2), and with a different position of the examined upper limb. During the first examination, the subject sat on a treatment table, feet resting on the floor. Upper limb examined in adduction, with bent elbow joint in the intermediate position between pronation and supination of the forearm. In the supine examination, the upper limb was stabilized against the subject's body (adduction in the shoulder joint, flexion in the elbow joint in an intermediate position). In each of the starting positions, first after putting on the glove, the range of passive motion in the radial-wrist joint (flexion and extension) and fingers (global flexion and extension) was measured, then the active movement was measured, in the sequence as above. Eventually, they were asked to make movements as quickly and as fully as possible. Measurement of the grip force with a dynamometer was performed in both analyzed starting positions after testing the ranges of motion and speed/frequency.
The Hand Tutor device and the EH 101 electronic hand dynamometer measuring the strength of the handgrip (measurement error 0.5 kg / 1 lb) were used to test the parameters of motor coordination and grip strength. The Hand Tutor is a device with a rehabilitation program and the ability to measure the range of passive and active movement, deficits of movement (error of measurement, 5 - 10 mm) as well as the speed/frequency of movement (error of measurement, 0,5 cycle/sec.).
- Conditions
- Stroke, Ischemic
- Being tested
- hand motor coordination in a sitting position after use TipStim Glove
- Keywords
- Tip Stim Glove device, motor coordination, grip strength, passive stabilization, stroke
- Medical subject headings
- Ischemic Stroke, 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 position after use TipStim GloveProcedure or surgery
Also called hand motor coordination in a supine position after use TipStim Glove
The next therapy with the use of Tip Stim took place after a week. The duration of each therapy session was 60 minutes. After the first therapy session and after a week, the parameters of movement coordination and handgrip were examined. The study of motor coordination and grip strength was performed in two different starting positions: sitting (no stabilization) and lying (with stabilization), and with a different position of the examined upper limb. The upper limb was examined in adduction, with the bent elbow joint in the intermediate position of the forearm. In each of the starting positions, first, the range of passive motion in the wrist joint (flexion and extension) and fingers (global flexion and extension) was measured, then the active movement was measured, in the sequence as above. Patients were asked to make movements as quickly and as fully as possible. Measurement of the grip force was performed after testing the ranges of motion and speed/frequency.
| Study group | Role | What they receive |
|---|---|---|
| The use of the active Tip Stim device to achieve coordinated of the hand. | Active comparator | Influence of the tested position and the use of the active TipStim Glove device on the improvement of motor coordination and grip force in patients after a stroke. Receives: Procedure: hand motor coordination in a sitting position after use TipStim Glove |
| The use of the passive Tip Stim device to achieve coordinated of the hand. | Placebo comparator | Influence of the tested position and the use of the passive TipStim Glove device on the improvement of motor coordination and grip force in patients after a stroke. Receives: Procedure: hand motor coordination in a sitting position after use TipStim Glove |
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
The Hand Tutor allows measuremnt of the range of passive movement (in mm)
Measured: up to 1 week
Range of active movement of the wrist, mm
The Hand Tutor allows measuremnt of the range of active movement (in mm)
Measured: up to 1 week
Wrist extension deficit, mm
The Hand Tutor allows measuremnt of the wrist extension deficit, (in mm)
Measured: up to 1 week
Wrist flexion deficit, mm
The Hand Tutor allows measuremnt of the wrist flexion deficit, (in mm)
Measured: up to 1 week
Maximum range of wrist movement
The Hand Tutor allows measuremnt of the maximum range of movement (in mm)
Measured: up to 1 week
Frequncy of wrist movement (flexion to extension), cycle#sec
The Hand Tutor allows measurement of the speed or frequency (i.e., the number of cycles per sec.)
Measured: up to 1 week
Assessment of the grip strength
A manual electronic dynamometer (EH 101) was used for grip strength measurement (kg)
Measured: up to 1 week
Range of passive movement of the fingers, mm
The Hand Tutor allows measuremnt of the range of fingers passive movement (in mm)
Measured: up to 1 week
Range of active movement of the fingers, mm
The Hand Tutor allows measuremnt of the range of fingers active movement (in mm)
Measured: up to 1 week
Fingers extension deficit, mm
The Hand Tutor allows measuremnt of the fingers extension deficit, (in mm)
Measured: up to 1 week
Fingers flexion deficit, mm
The Hand Tutor allows measuremnt of the fingers flexion deficit, (in mm)
Measured: up to 1 week
Maximum range of fingers movement
The Hand Tutor allows measuremnt of the maximum range of movement (in mm)
Measured: up to 1 week
Frequncy of fingers movement (flexion to extension), cycle#sec
The Hand Tutor allows measurement of the speed or frequency (i.e., the number of cycles per sec.)
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 posted1 Apr 2021
- Study start10 Jul 2019
- Primary completion14 Feb 2020
- Study completion14 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 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
- NCT04825405
- Sponsor's protocol ID
- 6/KRN/2019
- Status last verified
- Mar 2021
- First submitted
- 28 Mar 2021
- Last updated
- 1 Apr 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 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Tested Position and the Use of the TipStim Glove Device on the Improvement of the Hand Motor Coordination After Stroke
- ClinicalTrials.gov ID
- NCT04825405
- Acronym / sponsor ID
- 6/KRN/2019
- Conditions
- Stroke, Ischemic
- Keywords
- Tip Stim Glove device, motor coordination, grip strength, passive stabilization, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Anna OlczakUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 1 Apr 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 study was to evaluate the use of the Tip Stim device to achieve coordinated movement and grip force in stroke patients under conditions of active and passive stabilization of the trunk.
Detailed description
To test the effectiveness of the Tip Stim device, each patient received (alternating) both the experimental and control treatments in a specific sequence to assess the coordination of human hand movement and the grip strength. The first therapy with the use of Tip Stim parameters (Ratio current time to pause time: 2 sec :5 sec; Ramp (rise time impulse): 0,3 sec; Frequency: 20 Hz; Pulse width: 300 µs). Another session (putting on the glove without setting any parameters) took place after a week (time to mute the effects of the intervention). The duration of each therapy session is 60 minutes. After the first therapeutic session and after a week, the parameters of movement coordination and hand grip were examined. The study of motor coordination and grip strength was performed in two different starting positions: sitting (no stabilization) (fig. 1) and lying (with stabilization) (fig. 2), and with a different position of the examined upper limb. During the first examination, the subject sat on a treatment table, feet resting on the floor. Upper limb examined in adduction, with bent elbow joint in the intermediate position between pronation and supination of the forearm. In the supine examination, the upper limb was stabilized against the subject's body (adduction in the shoulder joint, flexion in the elbow joint in an intermediate position). In each of the starting positions, first after putting on the glove, the range of passive motion in the radial-wrist joint (flexion and extension) and fingers (global flexion and extension) was measured, then the active movement was measured, in the sequence as above. Eventually, they were asked to make movements as quickly and as fully as possible. Measurement of the grip force with a dynamometer was performed in both analyzed starting positions after testing the ranges of motion and speed/frequency.
The Hand Tutor device and the EH 101 electronic hand dynamometer measuring the strength of the handgrip (measurement error 0.5 kg / 1 lb) were used to test the parameters of motor coordination and grip strength. The Hand Tutor is a device with a rehabilitation program and the ability to measure the range of passive and active movement, deficits of movement (error of measurement, 5 - 10 mm) as well as the speed/frequency of movement (error of measurement, 0,5 cycle/sec.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The use of the active Tip Stim device to achieve coordinated of the hand. | Active comparator | Procedure: hand motor coordination in a sitting position after use TipStim GloveInfluence of the tested position and the use of the active TipStim Glove device on the improvement of motor coordination and grip force in patients after a stroke. |
| The use of the passive Tip Stim device to achieve coordinated of the hand. | Placebo comparator | Procedure: hand motor coordination in a sitting position after use TipStim GloveInfluence of the tested position and the use of the passive TipStim Glove device on the improvement of motor coordination and grip force in patients after a stroke. |
Who may qualify
- Ages
- 42 to 89 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 position after use TipStim GloveAlso: hand motor coordination in a supine position after use TipStim GloveThe next therapy with the use of Tip Stim took place after a week. The duration of each therapy session was 60 minutes. After the first therapy session and after a week, the parameters of movement coordination and handgrip were examined. The study of motor coordination and grip strength was performed in two different starting positions: sitting (no stabilization) and lying (with stabilization), and with a different position of the examined upper limb. The upper limb was examined in adduction, with the bent elbow joint in the intermediate position of the forearm. In each of the starting positions, first, the range of passive motion in the wrist joint (flexion and extension) and fingers (global flexion and extension) was measured, then the active movement was measured, in the sequence as above. Patients were asked to make movements as quickly and as fully as possible. Measurement of the grip force was performed after testing the ranges of motion and speed/frequency. | Procedure or surgery | The use of the active Tip Stim device to achieve coordinated of the hand., The use of the passive Tip Stim device to achieve coordinated of the hand. |
Primary outcome
Range of passive movement of the wrist, mm
Time frame: up to 1 week
The Hand Tutor allows measuremnt of the range of passive movement (in mm)
Range of active movement of the wrist, mm
Time frame: up to 1 week
The Hand Tutor allows measuremnt of the range of active movement (in mm)
Wrist extension deficit, mm
Time frame: up to 1 week
The Hand Tutor allows measuremnt of the wrist extension deficit, (in mm)
Wrist flexion deficit, mm
Time frame: up to 1 week
The Hand Tutor allows measuremnt of the wrist flexion deficit, (in mm)
Maximum range of wrist movement
Time frame: up to 1 week
The Hand Tutor allows measuremnt of the maximum range of movement (in mm)
Frequncy of wrist movement (flexion to extension), cycle#sec
Time frame: up to 1 week
The Hand Tutor allows measurement of the speed or frequency (i.e., the number of cycles per sec.)
Assessment of the grip strength
Time frame: up to 1 week
A manual electronic dynamometer (EH 101) was used for grip strength measurement (kg)
Range of passive movement of the fingers, mm
Time frame: up to 1 week
The Hand Tutor allows measuremnt of the range of fingers passive movement (in mm)
Range of active movement of the fingers, mm
Time frame: up to 1 week
The Hand Tutor allows measuremnt of the range of fingers active movement (in mm)
Fingers extension deficit, mm
Time frame: up to 1 week
The Hand Tutor allows measuremnt of the fingers extension deficit, (in mm)
Fingers flexion deficit, mm
Time frame: up to 1 week
The Hand Tutor allows measuremnt of the fingers flexion deficit, (in mm)
Maximum range of fingers movement
Time frame: up to 1 week
The Hand Tutor allows measuremnt of the maximum range of movement (in mm)
Frequncy of fingers movement (flexion to extension), cycle#sec
Time frame: up to 1 week
The Hand Tutor allows measurement of the speed or frequency (i.e., the number of cycles per sec.)
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 1 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Stroke, Ischemic
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
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 position after use TipStim Glove in people with Stroke, Ischemic, 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 1 Apr 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. Some participants in this study may receive a placebo. 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 (time frame: up to 1 week). 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 1 Apr 2021.