Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675958
Recruitment Status : Not yet recruiting
First Posted : September 18, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
María Juliana González Silva, Universidad Industrial de Santander

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.


Condition or disease Intervention/treatment Phase
Spasticity as Sequela of Stroke Other: Johnstone's Pressure Splint Other: Stretching Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized experimental study with two intervention groups will be performed. Control group (GS): Stretching and experimental group: (GJPS + S): Johnstone´s Pressure Splint plus Stretching.
Masking: Single (Investigator)
Masking Description: The evaluator does not know the assignment of the participants to the intervention group.
Primary Purpose: Treatment
Official Title: Immediate Effect of Johnstone's Pressure Splint Added to Stretching on the Spasticity of Elbow Flexors and Wrist in Cerebrovascular Disease (CVD).
Estimated Study Start Date : September 24, 2018
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : March 31, 2019

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




Primary Outcome Measures :
  1. Muscular tone of wrist and elbow flexors. [ Time Frame: before (baseline) and immediately after the intervention (maximum 10 minutes after the intervention). ]
    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.

  2. Reflex excitability of the flexor carpi radialis. [ Time Frame: before (baseline) and immediately after the intervention (maximum 10 minutes after the intervention). ]
    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).

  3. Joint kinematics in Functional Reach Pattern [ Time Frame: before (baseline) and immediately after the intervention (maximum 10 minutes after the intervention). ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675958


Contacts
Layout table for location contacts
Contact: Maria Juliana González Silva (057) + 3166208712 majugonza@hotmail.com

Sponsors and Collaborators
Universidad Industrial de Santander
Investigators
Layout table for investigator information
Principal Investigator: Maria Juliana González Silva Universidad Industrial de Santander
Layout table for additonal information
Responsible Party: María Juliana González Silva, Physiotherapist, Universidad Industrial de Santander
ClinicalTrials.gov Identifier: NCT03675958    
Other Study ID Numbers: UISantander
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It is not contended to share the data.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by María Juliana González Silva, Universidad Industrial de Santander:
H Reflex
Johnstone's Pressure Splint
Stretching
Functional Reach
Spasticity
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Spasticity
Cerebrovascular Disorders
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases