Spasticity as Sequela of StrokeNCT03675958
Immediate Effect of Johnstone's Pressure Splint Added to Stretching on the Spasticity in Cerebrovascular Disease.
A study testing Johnstone's Pressure Splint and Stretching in people with Spasticity as Sequela of Stroke, run by Universidad Industrial de Santander.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Spasticity as Sequela of Stroke
- What is being tested?
- Johnstone's Pressure Splint and Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 24 Sep 2018to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Immediate Effect of Johnstone's Pressure Splint Added to Stretching on the Spasticity of Elbow Flexors and Wrist in Cerebrovascular Disease (CVD).
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.
Read more
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.
- Conditions
- Spasticity as Sequela of Stroke
- Being tested
- Johnstone's Pressure Splint, Stretching
- Keywords
- H Reflex, Johnstone's Pressure Splint, Stretching, Functional Reach, Spasticity
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Johnstone's Pressure SplintOther
the intervention consists in the application of two tools used for the treatment of spasticity post - CVD. Johnstone's Pressure Splint added Stretching
StretchingOther
the intervention consists in the application of one tool used for the treatment of spasticity post - CVD. Just Stretching
| Study group | Role | What they receive |
|---|---|---|
| GJPS + S | Experimental | Experimental group: (GJPS + S) : Application Johnstone´s Pressure Splint plus Stretching in in 4 different treatment postures. Receives: Other: Johnstone's Pressure Splint; Other: Stretching |
| GS | Active comparator | Control group (GS): Just Stretching in 4 different treatment postures. Receives: Other: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before (baseline) and immediately after the intervention (maximum 10 minutes after the intervention).
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).
Measured: before (baseline) and immediately after the intervention (maximum 10 minutes after the intervention).
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.
Measured: before (baseline) and immediately after the intervention (maximum 10 minutes after the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start24 Sep 2018 (estimated)
- Primary completion15 Dec 2018 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity as Sequela of StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Industrial de Santander
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Juliana González Silva, Universidad Industrial de Santander
- Investigators
- Maria Juliana González Silva, Principal investigator, Universidad Industrial de Santander
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675958
- Sponsor's protocol ID
- UISantander
- Status last verified
- Sep 2018
- First submitted
- 1 Sep 2018
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not contended to share the data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Johnstone's Pressure Splint Added to Stretching on the Spasticity of Elbow Flexors and Wrist in Cerebrovascular Disease (CVD).
- ClinicalTrials.gov ID
- NCT03675958
- Acronym / sponsor ID
- UISantander
- Conditions
- Spasticity as Sequela of Stroke
- Keywords
- H Reflex, Johnstone's Pressure Splint, Stretching, Functional Reach, Spasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidad Industrial de SantanderUniversity, hospital or other
- Study start
- 24 Sep 2018 (estimated)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| GJPS + S | Experimental | Other: Johnstone's Pressure Splint, Other: StretchingExperimental group: (GJPS + S) : Application Johnstone´s Pressure Splint plus Stretching in in 4 different treatment postures. |
| GS | Active comparator | Other: StretchingControl group (GS): Just Stretching in 4 different treatment postures. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Johnstone's Pressure Splintthe intervention consists in the application of two tools used for the treatment of spasticity post - CVD. Johnstone's Pressure Splint added Stretching | Other | GJPS + S |
| Stretchingthe intervention consists in the application of one tool used for the treatment of spasticity post - CVD. Just Stretching | Other | GJPS + S, GS |
Primary outcome
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.
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).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Individual participant dataSharing planned: No. It is not contended to share the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Juliana González Silva principal investigator
Universidad Industrial de Santander
Questions about this trial
What is this clinical trial studying?
A study testing Johnstone's Pressure Splint and Stretching in people with Spasticity as Sequela of Stroke, run by Universidad Industrial de Santander.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Juliana González Silva ((057) + 3166208712, majugonza@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscular tone of wrist and elbow flexors. (time frame: before (baseline) and immediately after the intervention (maximum 10 minutes after the intervention).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.