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Completed

NCT Number: NCT04771533

Passive Stabilization of the Trunk and Upper Arm in Hand Rehabilitation After Stroke

This study aimed to assess correlations between muscle tone, stabilization of the trunk and the upper extremity, and parameters of hand/wrist motor coordination in post-stroke patients and neurologically healthy subjects with lower back pain.

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Key information

Conditions

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

Age range

44 year–83 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Military Institute of Medicine

Warsaw, Masovian District, 04-141, Poland

About this study

A Luna electromyography (EMG) (EGZOTech) was used to measure muscle tension, and a manual electronic dynamometer (EH 101) was used for grip strength measurement (error of measurement, 0.5 kg/lb). A Hand Tutor device (composed of a safe and comfortable glove equipped with position and motion sensors, and the Medi Tutor (TM) software was used to measure the range of passive and active movement, as well as the speed/frequency of movement. The Hand Tutor glove was worn on the hand of the directly affected side in stroke patients and on the dominant extremity in patients with pain syndrome. Surface electrodes (single-use 55' and '40 mm; ECG Electrodes; limited liability company and limited partnership (Sorimex), Poland were affixed to the subject's body according to the SENIAM (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles) procedure on the transverse abdominal, multifidus, and supraspinal muscles (on the side directly affected in stroke patients, and on the dominant side in patients with back pain syndrome). Before each exercise, the subject was instructed on how the exercise should be done.

The examination consisted of two motor tasks, carried out in two different starting positions: sitting and lying down (supine).

During the first examination, the subject sat on the therapeutic table (without back support), feet resting on the floor. The upper limb was examined in adduction of the humeral joint, with the elbow bent in the intermediate position between pronation and supination of the forearm, with free wrist and the hand.

In the supine position, the upper limb was stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position, wrist and hand free).

In each of the starting positions, after putting the glove on, the range of passive movement in the radial-carpal joint (flexion and extension) and fingers (global flexion and extension) was measured. Then the subject made active movement in the same order. Finally, the subject was asked to make moves as quickly and in as full a range as possible. Finally, the measurement of grip strength with a dynamometer was performed in both analyzed starting positions, after completing the range of motion and speed or frequency tests.

First, the range of passive movement in the radial-carpal joint (flexion and extension) and fingers (global flexion and extension) was measured in each position (sitting or supine) using the Hand Tutor Device. Then the subject made active movements in the same order. Finally, the subject was asked to make moves as quickly and in as full a range as possible. The measurement of grip strength with a dynamometer was performed in both positions (sitting or supine) after the range of motion and speed/frequency tests. The reaction of the examined multifidus, transverse abdominal, and supraspinatus muscles (tension values reported in microvolts (µV) was also assessed during each of the exercise tasks using the surface electrodes (i.e., during movement of the wrist and during movement of the fingers).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Study Group

Inclusion criteria

  • patients with hemiparesis 5 to 7 week after stroke;
  • no severe deficits in communication, memory, or understanding what can impede proper measurement performance;
  • at least 40 years of age.

Exclusion criteria

  • stroke up to five weeks after the episode;
  • epilepsy;
  • lack of trunk stability;
  • no wrist and hand movement;
  • high or very low blood pressure;
  • dizziness;
  • malaise.

Control Group

Inclusion criteria

  • no upper extremity motor coordination disorders
  • at least 40 years of age

Exclusion criteria

  • history of neurologic or musculoskeletal disorders such as carpal tunnel syndrome, tendonitis, stroke, head injury, or other conditions that could affect the ability for active movement and handgrip;
  • severe deficits in communication, memory, or understanding which could impede proper measurement performance;
  • high or very low blood pressure;
  • dizziness;
  • malaise

Treatment and study plan

hand motor coordination in a sitting position

Procedure

The subject sat on the therapeutic table (without back support), feet resting on the floor. The upper limb was to be examined in adduction of the humeral joint, with the elbow bent in the intermediate position between pronation and supination of the forearm, with free wrist and the hand. After putting the glove on, the range of passive movement in the radial-carpal joint (flexion and extension) and fingers (global flexion and extension) was measured. Then the subject made active movement in the same order. Finally, the subject was asked to make moves as quickly and in as full a range as possible. Finally, the measurement of grip strength with a dynamometer was performed.

hand motor coordination in a supine position

Procedure

In the supine position, the upper limb was stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position, wrist and the hand free). After putting the glove on, the range of passive movement in the radial-carpal joint (flexion and extension) and fingers (global flexion and extension) was measured. Then the subject made active movement in the same order. Finally, the subject was asked to make moves as quickly and in as full a range as possible. Finally, the measurement of grip strength with a dynamometer was performed.

Primary outcomes

  1. Range of passive movement of the wrist, mm 1st, 2nd, 3rd, 4th, 5th finger passive movement, mm

    Time frame: up to 10 weeks

    The Hand Tutor allows measurements of the range of passive movement (in mm).

  2. Assessment of the grip strength

    Time frame: up to 10 weeks

    Grip strength, kg (a manual electronic dynamometer (EH 101) was used for grip strength measurement (error of measurement, 0.5 kg/lb)

  3. Assessment of the muscle tension

    Time frame: up to 10 weeks

    A Luna electromyography (EMG) (a rehabilitation-diagnostic robot developed by EGZOTech) was used to measure muscle tension. Surface electrodes (single-use 55' and '40 mm; ECG Electrode; limited liability company, limited partnership (Sorimex), Poland) were affixed to the subject's body according to the Surface Electromyography for the Non-Invasive Assessment of Muscles (SENIAM) procedure on the transverse abdominal, multifidus, and supraspinal muscles.

  4. Range of active movement of the wrist, mm 1st, 2nd, 3rd, 4th, 5th finger active movement, mm

    Time frame: up to 10 weeks

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

  5. Wrist extension deficit, mm 1st, 2nd, 3rd, 4th, 5th finger extension deficit, mm

    Time frame: up to 10 weeks

    The Hand Tutor allows measurements of the extension deficit. The extension deficit refers to the difference between passive and active extension ROM.

  6. Wrist flexion deficit, mm 1st, 2nd, 3rd, 4th, 5th finger flexion deficit, mm

    Time frame: up to 10 weeks

    The Hand Tutor allows measurements of the flexion deficit. The flexion deficit refers to the difference between passive and active flexion ROM.

  7. Wrist maximum range of motion (ROM), mm 1st, 2nd, 3rd, 4th, 5th finger maximum range of motion (ROM), mm

    Time frame: up to 10 weeks

    The Hand Tutor allows measurements of the maximum range of motion (ROM).

    ROM is a sum of the wrist flexion or extension angles (mm). ROM is a sum of all the finger flexion or extension angles (i.e. at the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints), mm.

  8. Frequency of wrist movement (flexion to extension), cycles#/sec Frequency of 1st, 2nd, 3rd, 4th, 5th finger movement (flexion to extension), cycles#/sec

    Time frame: up to 10 weeks

    The Hand Tutor allows measurements the speed or frequency (i.e., the number of cycles per second, where one cycle represents the movement from flexion to contraction).

Sponsors and collaborators

Lead sponsor

Anna Olczak

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 25, 2021
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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