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
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
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
NCT ID
NCT03675958
First Posted
September 1, 2018
Last Updated
September 18, 2018
Sponsor
Universidad Industrial de Santander
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.
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Immediate Effect of Johnstone's Pressure Splint Added to Stretching on the Spasticity in Cerebrovascular Disease.
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