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

30. marts 2021 opdateret af: Anna Olczak

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.

Studieoversigt

Detaljeret beskrivelse

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.).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

29

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Masovian District
      • Warsaw, Masovian District, Polen, 04-141
        • Anna Olczak

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

42 år til 89 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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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Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: The use of the active Tip Stim device to achieve coordinated of the hand.
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.
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.
Andre navne:
  • hand motor coordination in a supine position after use TipStim Glove
Placebo komparator: The use of the passive Tip Stim device to achieve coordinated of the hand.
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.
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.
Andre navne:
  • hand motor coordination in a supine position after use TipStim Glove

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Range of passive movement of the wrist, mm
Tidsramme: up to 1 week
The Hand Tutor allows measuremnt of the range of passive movement (in mm)
up to 1 week
Range of active movement of the wrist, mm
Tidsramme: up to 1 week
The Hand Tutor allows measuremnt of the range of active movement (in mm)
up to 1 week
Wrist extension deficit, mm
Tidsramme: up to 1 week
The Hand Tutor allows measuremnt of the wrist extension deficit, (in mm)
up to 1 week
Wrist flexion deficit, mm
Tidsramme: up to 1 week
The Hand Tutor allows measuremnt of the wrist flexion deficit, (in mm)
up to 1 week
Maximum range of wrist movement
Tidsramme: up to 1 week
The Hand Tutor allows measuremnt of the maximum range of movement (in mm)
up to 1 week
Frequncy of wrist movement (flexion to extension), cycle#sec
Tidsramme: up to 1 week
The Hand Tutor allows measurement of the speed or frequency (i.e., the number of cycles per sec.)
up to 1 week
Assessment of the grip strength
Tidsramme: up to 1 week
A manual electronic dynamometer (EH 101) was used for grip strength measurement (kg)
up to 1 week
Range of passive movement of the fingers, mm
Tidsramme: up to 1 week
The Hand Tutor allows measuremnt of the range of fingers passive movement (in mm)
up to 1 week
Range of active movement of the fingers, mm
Tidsramme: up to 1 week
The Hand Tutor allows measuremnt of the range of fingers active movement (in mm)
up to 1 week
Fingers extension deficit, mm
Tidsramme: up to 1 week
The Hand Tutor allows measuremnt of the fingers extension deficit, (in mm)
up to 1 week
Fingers flexion deficit, mm
Tidsramme: up to 1 week
The Hand Tutor allows measuremnt of the fingers flexion deficit, (in mm)
up to 1 week
Maximum range of fingers movement
Tidsramme: up to 1 week
The Hand Tutor allows measuremnt of the maximum range of movement (in mm)
up to 1 week
Frequncy of fingers movement (flexion to extension), cycle#sec
Tidsramme: up to 1 week
The Hand Tutor allows measurement of the speed or frequency (i.e., the number of cycles per sec.)
up to 1 week

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Anna Olczak, PhD, Military Institute of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. juli 2019

Primær færdiggørelse (Faktiske)

14. februar 2020

Studieafslutning (Faktiske)

14. februar 2020

Datoer for studieregistrering

Først indsendt

28. marts 2021

Først indsendt, der opfyldte QC-kriterier

30. marts 2021

Først opslået (Faktiske)

1. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. marts 2021

Sidst verificeret

1. marts 2021

Mere information

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