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

NCT04771533 | Completed

• 1 other identifier: 3/KRN/2019
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

stroke; core stability; muscle tone; hand coordination

Outcome Measures

Primary Outcomes (8)

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

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

  up to 10 weeks

• Assessment of the grip strength

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

  up to 10 weeks

• Assessment of the muscle tension

  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.

  up to 10 weeks

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

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

  up to 10 weeks

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

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

  up to 10 weeks

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

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

  up to 10 weeks

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

  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.

  up to 10 weeks

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

  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).

  up to 10 weeks

Study Arms (1)

Passive stabilization of the trunk and the upper extremity

EXPERIMENTAL

The intervention (passive stabilization of the trunk and the upper arm) was tested in post-stroke patients (study group) and in patients with back pain, but without neurological deficits (control group)

Procedure: hand motor coordination in a sitting position; Procedure: hand motor coordination in a supine position

Interventions

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.

Passive stabilization of the trunk and the upper extremity

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.

Passive stabilization of the trunk and the upper extremity

Eligibility Criteria

• Age: 44 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Anna Olczak: lead

Study Sites (1)

Military Institute of Medicine

Warsaw, Masovian District, 04-141, Poland

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Anna Olczak, MD

  Rehabilitation Clinic, Military Institute of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 25, 2021
• Study Start: August 5, 2019
• Primary Completion: September 10, 2019
• Study Completion: September 10, 2019
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)