Immediate Effect of Johnstone's Pressure Splint Added to Stretching on the Spasticity in Cerebrovascular Disease.

Immediate Effect of Johnstone's Pressure Splint Added to Stretching on the Spasticity of Elbow Flexors and Wrist in Cerebrovascular Disease (CVD).

TITLE: Immediate effect of Johnstone's Pressure Splint added to Stretching on the spasticity of elbow flexors and wrist in Cerebrovascular Disease (CVD).

INTRODUCTION: In the rehabilitation of the upper limb post-CVD to employed exercise modalities such as stretching (S) to control spasticity, improve mobility and functionality. Also it is used the Johnstone´s Pressure Splint (JPS), which exerts circumferential pressure and contribute to spastic pattern inhibition, sensory re-education and increased of the mobility.

OBJECTIVE: The aim of the study is to evaluate the immediate effect of JPS added to S on the spasticity of elbow flexors and wrist, the reflex excitability and the joint kinematics in Stroke.

MATERIALS AND METHODS: A randomized experimental study with two intervention groups will be performed. Control group (GS): Stretching and experimental group: (GJPS + S): JPS plus S. Measurement times: Before the intervention (T0) and immediately post- intervention (T1). The outcome variables are muscle tone of elbow, wrist and hand assessed with the Modified Ashworth Scale (MAS); H reflex of the Flexor Carpi Radialis muscle, latency (ms), duration (ms) and amplitude (mV) of the M and H waves, and the amplitude the Hmax / Mmax ratio (%). Shoulder, elbow and trunk angles (degrees), trunk displacement (cm) and duration (sec) of the Functional Reach Pattern (PAF) will be evaluated with the software Contemplas.

ANALYSIS: Descriptive statistics will be applied and Shapiro Wilk test to evaluate the normality of the variables. Intra-group differences will be assessed with the student t-test paired and intergroup with the student t-test unpaired or the sum of Wilcoxon rank according to the distribution of the variables.

EXPECTED RESULTS: Hypotheses and contributions to the scientific evidence on the immediate effect of the S and JPS will be generated, to support the JPS as a complement to the traditional treatment. The results will be socialized in an international scientific event and a publication will be submitted to an impact journal.

KEY WORDS: Spasticity, H Reflex, Johnstone's Pressure Splint, Stretching, Functional Reach.

Study Overview

• Status: Unknown
• Conditions: Spasticity as Sequela of Stroke
• Intervention / Treatment: Other: Johnstone's Pressure Splint; Other: Stretching

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Medical diagnosis of CVD.
• Minimum evolution time from 6 months to 48 months.
• Muscular tone according to the Modified Ashworth Scale> a 1+ in the elbow and wrist flexors.
• Maintain seated position without human support or assistance for at least 10 seconds and maintain standing position for more than 30 seconds to perform transfers from one surface to another.

Exclusion Criteria:

• Altered cognitive ability, assessed through the "Short Portable Mental State Questionnaire".
• Application of botulinum toxin within six (6) months prior to participation in the study.
• Patients with skin lesions, lacerations or allergies.
• People with pacemaker.
• People in whom the H reflex can not be evoked.
• Pain and hyperalgesia in the upper limb.
• Peripheral vascular disease in upper limb.
• Fractures, or musculoskeletal injuries in the paretic upper limb less than a year old.
• Osteoarthritis, rheumatoid arthritis and clinical conditions associated with acute pain, inflammation, and moderate to severe decrease in joint mobility.
• Consumption of drugs such as Baclofen, benzodiazepines, or muscle relaxants such as dantrolene and tizanidine.
• Ingestion of caffeine and alcohol 12 hours before evaluations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GJPS + S; Experimental group: (GJPS + S) : Application Johnstone´s Pressure Splint plus Stretching in in 4 different treatment postures.	Other: Johnstone's Pressure Splint; the intervention consists in the application of two tools used for the treatment of spasticity post - CVD. Johnstone's Pressure Splint added Stretching; Other: Stretching; the intervention consists in the application of one tool used for the treatment of spasticity post - CVD. Just Stretching
ACTIVE_COMPARATOR: GS; Control group (GS): Just Stretching in 4 different treatment postures.	Other: Stretching; the intervention consists in the application of one tool used for the treatment of spasticity post - CVD. Just Stretching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscular tone of wrist and elbow flexors.	Defined as the resistance to movement of passive movement, it will be evaluated by the Modified Ashworth Scale (EAM) in flexo-extensors of the elbow and wrist and hand. (Ordinal scale of 6 points, with a range from 0 = normal tone to 4 = rigid segment in flexion or extension) .109 The EAM includes an additional degree of 1+, which has a sub-classification between an increase level and an increase of speed in the tone.	before (baseline) and immediately after the intervention (maximum 10 minutes after the intervention).
Reflex excitability of the flexor carpi radialis.	Excitability is a specific property of muscle and nerve tissue and occurs when depolarization exceeds the threshold level in the action potential. The excitability will be measured from the evocation of H Reflex in the flexor carpi radialis muscle (FRC).	before (baseline) and immediately after the intervention (maximum 10 minutes after the intervention).
Joint kinematics in Functional Reach Pattern	Shoulder, elbow and trunk angles (degrees), trunk displacement (cm) and duration (sec) of the Functional Reach Pattern (PAF) will be evaluated with the software Contemplas.	before (baseline) and immediately after the intervention (maximum 10 minutes after the intervention).

Collaborators and Investigators

• Sponsor: Universidad Industrial de Santander
• Investigators: Principal Investigator: Maria Juliana González Silva, Universidad Industrial de Santander

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 24, 2018
• Primary Completion (ANTICIPATED): December 15, 2018
• Study Completion (ANTICIPATED): March 31, 2019

Study Registration Dates

• First Submitted: September 1, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (ACTUAL): September 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2018
• Last Update Submitted That Met QC Criteria: September 18, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Spasticity; Stretching; H Reflex; Johnstone's Pressure Splint; Functional Reach
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity; Cerebrovascular Disorders
• Other Study ID Numbers: UISantander

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is not contended to share the data.

Drug and device information, study documents

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