CClinicalTrials.gg
Status unknownNCT03675958Updated Sep 19, 2018

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

An interventional study of Johnstone's Pressure Splint and Stretching in Spasticity as Sequela of Stroke, sponsored by Universidad Industrial de Santander. Status unknown. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-09-19.

Sponsored by Universidad Industrial de Santander · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
50 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Spasticity as Sequela of Stroke

Keywords

  • H Reflex
  • Johnstone's Pressure Splint
  • Stretching
  • Functional Reach
  • Spasticity
03

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
20 participants (estimated)

Study arms

  • 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 · Other: Stretching

  • Active comparator
    GS

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

    Other: Stretching

Interventions

  • OtherJohnstone'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

  • OtherStretching

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: before (baseline) and immediately after the intervention (maximum 10 minutes after the intervention).

  2. 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).

    Time frame: before (baseline) and immediately after the intervention (maximum 10 minutes after the intervention).

  3. 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.

    Time frame: before (baseline) and immediately after the intervention (maximum 10 minutes after the intervention).

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No — It is not contended to share the data.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03675958
Lead sponsor
Universidad Industrial de Santander
Responsible party
María Juliana González Silva (Physiotherapist, Universidad Industrial de Santander) — Principal investigator
First posted
Sep 18, 2018
Start date
Sep 24, 2018 (estimated)
Primary completion
Dec 15, 2018 (estimated)
Completion
Mar 31, 2019 (estimated)
Last update
Sep 19, 2018

Study contacts

Maria Juliana González Silva
Contact
majugonza@hotmail.com
(057) + 3166208712
Maria Juliana González Silva
principal investigator · Universidad Industrial de Santander

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion