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

30. März 2021 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.).

Studientyp

Interventionell

Einschreibung (Tatsächlich)

29

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

42 Jahre bis 89 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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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Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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.
Andere Namen:
  • 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.
Andere Namen:
  • hand motor coordination in a supine position after use TipStim Glove

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Range of passive movement of the wrist, mm
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: up to 1 week
The Hand Tutor allows measuremnt of the wrist extension deficit, (in mm)
up to 1 week
Wrist flexion deficit, mm
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: up to 1 week
The Hand Tutor allows measuremnt of the fingers extension deficit, (in mm)
up to 1 week
Fingers flexion deficit, mm
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ermittler

  • Hauptermittler: Anna Olczak, PhD, Military Institute of Medicine

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

10. Juli 2019

Primärer Abschluss (Tatsächlich)

14. Februar 2020

Studienabschluss (Tatsächlich)

14. Februar 2020

Studienanmeldedaten

Zuerst eingereicht

28. März 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. März 2021

Zuerst gepostet (Tatsächlich)

1. April 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. April 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. März 2021

Zuletzt verifiziert

1. März 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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