Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-22 @ 9:38 AM
Study NCT ID:
NCT03675958
Status:
UNKNOWN
Last Update Posted:
2018-09-19
First Post:
2018-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Effect of Johnstone's Pressure Splint Added to Stretching on the Spasticity in Cerebrovascular Disease.
Sponsor:
Universidad Industrial de Santander
Organization:
Study Overview
Official Title:
Immediate Effect of Johnstone's Pressure Splint Added to Stretching on the Spasticity of Elbow Flexors and Wrist in Cerebrovascular Disease (CVD).
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: