Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

30 mars 2021 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.).

Type d'étude

Interventionnel

Inscription (Réel)

29

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

42 ans à 89 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

-

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Autres noms:
  • hand motor coordination in a supine position after use TipStim Glove
Comparateur placebo: 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.
Autres noms:
  • hand motor coordination in a supine position after use TipStim Glove

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Range of passive movement of the wrist, mm
Délai: 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
Délai: 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
Délai: up to 1 week
The Hand Tutor allows measuremnt of the wrist extension deficit, (in mm)
up to 1 week
Wrist flexion deficit, mm
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: up to 1 week
The Hand Tutor allows measuremnt of the fingers extension deficit, (in mm)
up to 1 week
Fingers flexion deficit, mm
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Anna Olczak, PhD, Military Institute of Medicine

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 juillet 2019

Achèvement primaire (Réel)

14 février 2020

Achèvement de l'étude (Réel)

14 février 2020

Dates d'inscription aux études

Première soumission

28 mars 2021

Première soumission répondant aux critères de contrôle qualité

30 mars 2021

Première publication (Réel)

1 avril 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 avril 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 mars 2021

Dernière vérification

1 mars 2021

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner