Effect of Local Pressure on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke

NCT04188769 | Withdrawn

• 1 other identifier: EC/2019/1776
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effect of - both constant as intermittent - local application of deep pressure on muscle activity and general relaxation in persons with hypertonia following stroke.

Conditions

Deep Pressure; Muscle Activity; General Relaxation; Stroke; Hypertonia, Muscle

Outcome Measures

Primary Outcomes (8)

• EMG of biceps brachii

  electromyographic frequency analysis of biceps brachii muscle activity at the hemiplegic side

  through study completion, an average of 5 months

• EMG of triceps brachii

  electromyographic frequency analysis of triceps brachii muscle activity at the hemiplegic side

  through study completion, an average of 5 months

• EMG of pectoralis major

  electromyographic frequency analysis of pectoralis major muscle activity at the hemiplegic side

  through study completion, an average of 5 months

• MyotonPRO measurement of pectoralis major muscle tone

  MyotonPRO measurement of pectoralis major muscle tone

  through study completion, an average of 5 months

• heart rate

  heart rate measurement assessed with the Zehpyr bioharness

  through study completion, an average of 5 months

• heart rate variability

  heart rate variability assessed with the Zehpyr bioharness

  through study completion, an average of 5 months

• respiratory rate

  respiratory rate assessed with the Zehpyr bioharness

  through study completion, an average of 5 months

• subjective rating of hypertonia

  visual analogue scale rating of the intensity of hypertonia, in which the degree of hypertonia has to be situated between "0" (no hypertonia) and "10" (very severe hypertonia)

  through study completion, an average of 5 months

Secondary Outcomes (2)

• MyotonPRO measurement of pectoralis major elasticity

  through study completion, an average of 5 months

• MyotonPRO measurement of pectoralis major stiffness

  through study completion, an average of 5 months

Study Arms (6)

uninflated - rest

SHAM COMPARATOR

splint around the arm is not inflated both arms are in rest during the entire trial

Device: uninflated air splint

uninflated - triggered

SHAM COMPARATOR

splint around the arm is not inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)

Device: uninflated air splint; Other: contralateral movement

constantly inflated - rest

ACTIVE COMPARATOR

splint around the arm is constantly inflated both arms are in rest during the entire trial

Device: constant deep pressure applied by an air splint

constantly inflated - triggered

ACTIVE COMPARATOR

splint around the arm is constantly inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)

Device: constant deep pressure applied by an air splint; Other: contralateral movement

intermittently inflated - rest

EXPERIMENTAL

splint around the arm is intermittently inflated both arms are in rest during the entire trial

Device: intermittent deep pressure applied by an air splint

intermittently inflated - triggered

EXPERIMENTAL

splint around the arm is intermittently inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)

Device: intermittent deep pressure applied by an air splint; Other: contralateral movement

Interventions

constant deep pressure applied by an air splint DEVICE

inflation of the Johnstone air splint gives a constant local deep pression on the hemiplegic arm

constantly inflated - rest; constantly inflated - triggered

intermittent deep pressure applied by an air splint DEVICE

continuous inflation and deflation of the Johnstone air splint gives an intermittent local deep pression on the hemiplegic arm

intermittently inflated - rest; intermittently inflated - triggered

uninflated air splint DEVICE

no deep pressure applied by the air splint

uninflated - rest; uninflated - triggered

contralateral movement OTHER

non-hemiplegic arm is flexed and extended 5 times, with a weight of 5kg in the hand, in order to trigger hypertonia in the hemiplegic arm

constantly inflated - triggered; intermittently inflated - triggered; uninflated - triggered

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• subacute stroke (\<6 months)
• hypertonia (Modified Ashworth Scale score of ≥2 for arm flexors at the hemiplegic side)

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University

Ghent, Belgium

Location

MeSH Terms

Conditions

Stroke; Muscle Hypertonia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 6, 2019
• Study Start: December 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: December 8, 2021

Record last verified: 2021-11

Locations

BE (1)