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

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Procedure: hand motor coordination in a sitting position after use TipStim Glove

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.).

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 42 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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.

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: hand motor coordination in a sitting position after use TipStim Glove; 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.; Other Names: hand motor coordination in a supine position after use TipStim Glove
Placebo Comparator: 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.	Procedure: hand motor coordination in a sitting position after use TipStim Glove; 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.; Other Names: hand motor coordination in a supine position after use TipStim Glove

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Anna Olczak
• Investigators: Principal Investigator: Anna Olczak, PhD, Military Institute of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2019
• Primary Completion (Actual): February 14, 2020
• Study Completion (Actual): February 14, 2020

Study Registration Dates

• First Submitted: March 28, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 30, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: stroke; grip strength; Tip Stim Glove device; motor coordination; passive stabilization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 6/KRN/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No