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

NCT04825405 | Completed

• 1 other identifier: 6/KRN/2019
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Keywords

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

Outcome Measures

Primary Outcomes (13)

• Range of passive movement of the wrist, mm

  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

  The Hand Tutor allows measuremnt of the range of active movement (in mm)

  up to 1 week

• Wrist extension deficit, mm

  The Hand Tutor allows measuremnt of the wrist extension deficit, (in mm)

  up to 1 week

• Wrist flexion deficit, mm

  The Hand Tutor allows measuremnt of the wrist flexion deficit, (in mm)

  up to 1 week

• Maximum range of wrist movement

  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

  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

  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

  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

  The Hand Tutor allows measuremnt of the range of fingers active movement (in mm)

  up to 1 week

• Fingers extension deficit, mm

  The Hand Tutor allows measuremnt of the fingers extension deficit, (in mm)

  up to 1 week

• Fingers flexion deficit, mm

  The Hand Tutor allows measuremnt of the fingers flexion deficit, (in mm)

  up to 1 week

• Maximum range of fingers movement

  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

  The Hand Tutor allows measurement of the speed or frequency (i.e., the number of cycles per sec.)

  up to 1 week

Study Arms (2)

The use of the active Tip Stim device to achieve coordinated of the hand.

ACTIVE COMPARATOR

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.

Procedure: hand motor coordination in a sitting position after use TipStim Glove

The use of the passive Tip Stim device to achieve coordinated of the hand.

PLACEBO COMPARATOR

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.

Procedure: hand motor coordination in a sitting position after use TipStim Glove

Interventions

hand motor coordination in a sitting position after use TipStim Glove PROCEDURE

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.

Also known as: hand motor coordination in a supine position after use TipStim Glove

The use of the active Tip Stim device to achieve coordinated of the hand.; The use of the passive Tip Stim device to achieve coordinated of the hand.

Eligibility Criteria

• Age: 42 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Anna Olczak: lead

Study Sites (1)

Anna Olczak

Warsaw, Masovian District, 04-141, Poland

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anna Olczak, PhD

  Military Institute of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD; Senior Specjalit of the Rehabilitation Clinc

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 1, 2021
• Study Start: July 10, 2019
• Primary Completion: February 14, 2020
• Study Completion: February 14, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)