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The Use of the Tip Stim Glove Device to Achieve Coordinated Movement of the Human Hand

Primary Purpose

Stroke, Ischemic

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
hand motor coordination in a sitting position after use TipStim Glove
Sponsored by
Anna Olczak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Tip Stim Glove device, motor coordination, grip strength, passive stabilization, stroke

Eligibility Criteria

42 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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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.

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Sites / Locations

  • Anna Olczak

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

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.

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Range of passive movement of the wrist, mm
The Hand Tutor allows measuremnt of the range of passive movement (in mm)
Range of active movement of the wrist, mm
The Hand Tutor allows measuremnt of the range of active movement (in mm)
Wrist extension deficit, mm
The Hand Tutor allows measuremnt of the wrist extension deficit, (in mm)
Wrist flexion deficit, mm
The Hand Tutor allows measuremnt of the wrist flexion deficit, (in mm)
Maximum range of wrist movement
The Hand Tutor allows measuremnt of the maximum range of movement (in mm)
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.)
Assessment of the grip strength
A manual electronic dynamometer (EH 101) was used for grip strength measurement (kg)
Range of passive movement of the fingers, mm
The Hand Tutor allows measuremnt of the range of fingers passive movement (in mm)
Range of active movement of the fingers, mm
The Hand Tutor allows measuremnt of the range of fingers active movement (in mm)
Fingers extension deficit, mm
The Hand Tutor allows measuremnt of the fingers extension deficit, (in mm)
Fingers flexion deficit, mm
The Hand Tutor allows measuremnt of the fingers flexion deficit, (in mm)
Maximum range of fingers movement
The Hand Tutor allows measuremnt of the maximum range of movement (in mm)
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.)

Secondary Outcome Measures

Full Information

First Posted
March 28, 2021
Last Updated
March 30, 2021
Sponsor
Anna Olczak
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1. Study Identification

Unique Protocol Identification Number
NCT04825405
Brief Title
The Use of the Tip Stim Glove Device to Achieve Coordinated Movement of the Human Hand
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 10, 2019 (Actual)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
February 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anna Olczak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
Tip Stim Glove device, motor coordination, grip strength, passive stabilization, stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The use of the active Tip Stim device to achieve coordinated of the hand.
Arm Type
Active Comparator
Arm Description
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.
Arm Title
The use of the passive Tip Stim device to achieve coordinated of the hand.
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
hand motor coordination in a sitting position after use TipStim Glove
Other Intervention Name(s)
hand motor coordination in a supine position after use TipStim Glove
Intervention Description
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.
Primary Outcome Measure Information:
Title
Range of passive movement of the wrist, mm
Description
The Hand Tutor allows measuremnt of the range of passive movement (in mm)
Time Frame
up to 1 week
Title
Range of active movement of the wrist, mm
Description
The Hand Tutor allows measuremnt of the range of active movement (in mm)
Time Frame
up to 1 week
Title
Wrist extension deficit, mm
Description
The Hand Tutor allows measuremnt of the wrist extension deficit, (in mm)
Time Frame
up to 1 week
Title
Wrist flexion deficit, mm
Description
The Hand Tutor allows measuremnt of the wrist flexion deficit, (in mm)
Time Frame
up to 1 week
Title
Maximum range of wrist movement
Description
The Hand Tutor allows measuremnt of the maximum range of movement (in mm)
Time Frame
up to 1 week
Title
Frequncy of wrist movement (flexion to extension), cycle#sec
Description
The Hand Tutor allows measurement of the speed or frequency (i.e., the number of cycles per sec.)
Time Frame
up to 1 week
Title
Assessment of the grip strength
Description
A manual electronic dynamometer (EH 101) was used for grip strength measurement (kg)
Time Frame
up to 1 week
Title
Range of passive movement of the fingers, mm
Description
The Hand Tutor allows measuremnt of the range of fingers passive movement (in mm)
Time Frame
up to 1 week
Title
Range of active movement of the fingers, mm
Description
The Hand Tutor allows measuremnt of the range of fingers active movement (in mm)
Time Frame
up to 1 week
Title
Fingers extension deficit, mm
Description
The Hand Tutor allows measuremnt of the fingers extension deficit, (in mm)
Time Frame
up to 1 week
Title
Fingers flexion deficit, mm
Description
The Hand Tutor allows measuremnt of the fingers flexion deficit, (in mm)
Time Frame
up to 1 week
Title
Maximum range of fingers movement
Description
The Hand Tutor allows measuremnt of the maximum range of movement (in mm)
Time Frame
up to 1 week
Title
Frequncy of fingers movement (flexion to extension), cycle#sec
Description
The Hand Tutor allows measurement of the speed or frequency (i.e., the number of cycles per sec.)
Time Frame
up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Olczak, PhD
Organizational Affiliation
Military Institute of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anna Olczak
City
Warsaw
State/Province
Masovian District
ZIP/Postal Code
04-141
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

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The Use of the Tip Stim Glove Device to Achieve Coordinated Movement of the Human Hand

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