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

NCT ID: NCT03675958

Last Updated: 2018-09-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-24
• Study Completion Date: 2019-03-31

Brief Summary

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.

Conditions

Spasticity as Sequela of Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

GJPS + S

Experimental group: (GJPS + S) : Application Johnstone´s Pressure Splint plus Stretching in in 4 different treatment postures.

Group Type: EXPERIMENTAL

Johnstone's Pressure Splint

Intervention Type: OTHER

the intervention consists in the application of two tools used for the treatment of spasticity post - CVD. Johnstone's Pressure Splint added Stretching

Stretching

Intervention Type: OTHER

the intervention consists in the application of one tool used for the treatment of spasticity post - CVD. Just Stretching

GS

Control group (GS): Just Stretching in 4 different treatment postures.

Group Type: ACTIVE_COMPARATOR

Stretching

Intervention Type: OTHER

the intervention consists in the application of one tool used for the treatment of spasticity post - CVD. Just Stretching

Interventions

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

Intervention Type: OTHER

Stretching

the intervention consists in the application of one tool used for the treatment of spasticity post - CVD. Just Stretching

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Industrial de Santander

OTHER

Sponsor Role: lead

Responsible Party

María Juliana González Silva

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Juliana González Silva

Role: PRINCIPAL_INVESTIGATOR

Universidad Industrial de Santander

Central Contacts

Maria Juliana González Silva

Role: CONTACT

majugonza@hotmail.com

(057) + 3166208712

Other Identifiers

UISantander

Identifier Type: -

Identifier Source: org_study_id