search
Back to results

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

Primary Purpose

Spasticity as Sequela of Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Johnstone's Pressure Splint
Stretching
Sponsored by
Universidad Industrial de Santander
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasticity as Sequela of Stroke focused on measuring H Reflex, Johnstone's Pressure Splint, Stretching, Functional Reach, Spasticity

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    GJPS + S

    GS

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.
    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).
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 1, 2018
    Last Updated
    September 18, 2018
    Sponsor
    Universidad Industrial de Santander
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03675958
    Brief Title
    Immediate Effect of Johnstone's Pressure Splint Added to Stretching on the Spasticity in Cerebrovascular Disease.
    Official Title
    Immediate Effect of Johnstone's Pressure Splint Added to Stretching on the Spasticity of Elbow Flexors and Wrist in Cerebrovascular Disease (CVD).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 24, 2018 (Anticipated)
    Primary Completion Date
    December 15, 2018 (Anticipated)
    Study Completion Date
    March 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Industrial de Santander

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spasticity as Sequela of Stroke
    Keywords
    H Reflex, Johnstone's Pressure Splint, Stretching, Functional Reach, Spasticity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Investigator
    Masking Description
    The evaluator does not know the assignment of the participants to the intervention group.
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    GJPS + S
    Arm Type
    Experimental
    Arm Description
    Experimental group: (GJPS + S) : Application Johnstone´s Pressure Splint plus Stretching in in 4 different treatment postures.
    Arm Title
    GS
    Arm Type
    Active Comparator
    Arm Description
    Control group (GS): Just Stretching in 4 different treatment postures.
    Intervention Type
    Other
    Intervention Name(s)
    Johnstone's Pressure Splint
    Intervention Description
    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
    Intervention Name(s)
    Stretching
    Intervention Description
    the intervention consists in the application of one tool used for the treatment of spasticity post - CVD. Just Stretching
    Primary Outcome Measure Information:
    Title
    Muscular tone of wrist and elbow flexors.
    Description
    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.
    Time Frame
    before (baseline) and immediately after the intervention (maximum 10 minutes after the intervention).
    Title
    Reflex excitability of the flexor carpi radialis.
    Description
    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).
    Time Frame
    before (baseline) and immediately after the intervention (maximum 10 minutes after the intervention).
    Title
    Joint kinematics in Functional Reach Pattern
    Description
    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.
    Time Frame
    before (baseline) and immediately after the intervention (maximum 10 minutes after the intervention).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maria Juliana González Silva
    Phone
    (057) + 3166208712
    Email
    majugonza@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria Juliana González Silva
    Organizational Affiliation
    Universidad Industrial de Santander
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    It is not contended to share the data.

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs