Clinical trial NCT04825405: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Keywords: Tip Stim Glove device
motor coordination
grip strength
passive stabilization
stroke
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 29
Sex: ALL
Minimum age (years): 42
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.).

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.

-

Primary outcomes:
measure: Range of passive movement of the wrist, mm
timeFrame: up to 1 week
measure: Range of active movement of the wrist, mm
timeFrame: up to 1 week
measure: Wrist extension deficit, mm
timeFrame: up to 1 week
measure: Wrist flexion deficit, mm
timeFrame: up to 1 week
measure: Maximum range of wrist movement
timeFrame: up to 1 week
measure: Frequncy of wrist movement (flexion to extension), cycle#sec
timeFrame: up to 1 week
measure: Assessment of the grip strength
timeFrame: up to 1 week
measure: Range of passive movement of the fingers, mm
timeFrame: up to 1 week
measure: Range of active movement of the fingers, mm
timeFrame: up to 1 week
measure: Fingers extension deficit, mm
timeFrame: up to 1 week
measure: Fingers flexion deficit, mm
timeFrame: up to 1 week
measure: Maximum range of fingers movement
timeFrame: up to 1 week
measure: Frequncy of fingers movement (flexion to extension), cycle#sec
timeFrame: up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Anna Olczak
state: Masovian District
Study officials:
affiliation: Military Institute of Medicine
name: Anna Olczak, PhD
role: PRINCIPAL_INVESTIGATOR
References: