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

Influence of the Tested Position and the Use of the TipStim Glove Device on the Improvement of the Hand Motor Coordination After Stroke

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04825405
Enrollment
29
Registered
2021-04-01
Start date
2019-07-10
Completion date
2020-02-14
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Ischemic

Keywords

Tip Stim Glove device, motor coordination, grip strength, passive stabilization, stroke

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.).

Interventions

PROCEDUREhand motor coordination in a sitting 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.

Sponsors

Anna Olczak
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
42 Years to 89 Years
Healthy volunteers
No

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. \-

Design outcomes

Primary

MeasureTime frameDescription
Range of passive movement of the wrist, mmup to 1 weekThe Hand Tutor allows measuremnt of the range of passive movement (in mm)
Range of active movement of the wrist, mmup to 1 weekThe Hand Tutor allows measuremnt of the range of active movement (in mm)
Wrist extension deficit, mmup to 1 weekThe Hand Tutor allows measuremnt of the wrist extension deficit, (in mm)
Wrist flexion deficit, mmup to 1 weekThe Hand Tutor allows measuremnt of the wrist flexion deficit, (in mm)
Maximum range of wrist movementup to 1 weekThe Hand Tutor allows measuremnt of the maximum range of movement (in mm)
Frequncy of wrist movement (flexion to extension), cycle#secup to 1 weekThe Hand Tutor allows measurement of the speed or frequency (i.e., the number of cycles per sec.)
Assessment of the grip strengthup to 1 weekA manual electronic dynamometer (EH 101) was used for grip strength measurement (kg)
Range of passive movement of the fingers, mmup to 1 weekThe Hand Tutor allows measuremnt of the range of fingers passive movement (in mm)
Range of active movement of the fingers, mmup to 1 weekThe Hand Tutor allows measuremnt of the range of fingers active movement (in mm)
Fingers extension deficit, mmup to 1 weekThe Hand Tutor allows measuremnt of the fingers extension deficit, (in mm)
Fingers flexion deficit, mmup to 1 weekThe Hand Tutor allows measuremnt of the fingers flexion deficit, (in mm)
Maximum range of fingers movementup to 1 weekThe Hand Tutor allows measuremnt of the maximum range of movement (in mm)
Frequncy of fingers movement (flexion to extension), cycle#secup to 1 weekThe Hand Tutor allows measurement of the speed or frequency (i.e., the number of cycles per sec.)

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026