HemiplegiaPhase 1REHELANCT01308216
Transcranial Laser Therapy in the Rehabilitation of Hemiplegic Patients From Ischemic Stroke
A Phase 1 study testing low level laser therapy procedure in people with Hemiplegia, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
The aim of this study is to determine the efficacy of transcranial laser therapy applied in automatic noncontact scanning mode for improving functional disability in patients with hemiplegia from ischemic stroke undergoing a rehabilitation program. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Hemiplegia
- What is being tested?
- low level laser therapy procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2010to Dec 2011
- Phase
- Phase 1
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hemiplegia secondary to cerebral stroke ischemic.
- Requirement of shaving the scalp area.
- Initiation of the TLT procedure begins between 70 and 100 days after stroke onset.
- Informed written consent before enrolling in the study.
Who cannot join
- Hemiplegia secondary to hemorrhagic stroke.
- Metallic brain implants.
- Neurodegenerative disorders.
- Bilateral motor problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Transcranial Laser Therapy for Improving Upper Extremity Functional Recovery in Hemiplegic Patients From Ischemic Stroke
The aim of this study is to determine the efficacy of transcranial laser therapy applied in automatic noncontact scanning mode for improving functional disability in patients with hemiplegia from ischemic stroke undergoing a rehabilitation program.
Read the detailed description
Transcranial laser therapy is applied with an InGa(Al)As diode laser.The laser in automatic scanning is applied over both cerebral hemisphere during 15 sessions. Patients simultaneously performed a program of therapeutic exercises 3 days a week. Outcome measures were the Fugl-Meyer Upper Extremity scale, which assessed upper limb motor function, and the Barthel index, which assessed general functional disability.
- Conditions
- Hemiplegia
- Being tested
- low level laser therapy procedure
- Keywords
- Transcranial Laser Therapy, Hemiplegia, Rehabilitation, Physiotherapy, Ischemic stroke
- Medical subject headings
- Hemiplegia, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser therapy procedureProcedure or surgery
Also called COMBY 3 Terza Serie C-LASER; ASA.
Transcranial low level laser therapy by automatic scanning noncontact over both cerebral hemispheres.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial low level laser therapy | Experimental | Transcranial laser therapy is applied by automatic scanning over both hemispheres and the patients undergoing also a standard rehabilitation program based on therapeutic exercises. Receives: Procedure: low level laser therapy procedure |
| Control | Active comparator | The patients undergoing only a standard rehabilitation program based on therapeutic exercises. Receives: Procedure: low level laser therapy procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Scale
The upper extremity Fugl-Meyer subscale (0-66) considers flexor and extensor synegies as well as reflex activity and coordination and is specific for grading motor impairments.
Measured: 20 minutes
Secondary outcomes (1)
Barthel index
Barthel index (0-100) is composed of 10 items and assesses activities related to clothing,nourishment,personal hygiene and transference.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionDec 2011
Why it stopped: Based in the negative of patients to shave de hair.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMON MONTES MOLINA, Hospital Universitario Ramon y Cajal
- Investigators
- Ramón Montes-Molina, PT, Principal investigator, Hospital University Ramon y Cajal. IRYCIS.Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308216
- Sponsor's protocol ID
- RyC-10
- Acronym
- REHELA
- Status last verified
- Nov 2011
- First submitted
- 3 Mar 2011
- Last updated
- 3 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transcranial Laser Therapy for Improving Upper Extremity Functional Recovery in Hemiplegic Patients From Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01308216
- Acronym / sponsor ID
- REHELA / RyC-10
- Conditions
- Hemiplegia
- Keywords
- Transcranial Laser Therapy, Hemiplegia, Rehabilitation, Physiotherapy, Ischemic stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based in the negative of patients to shave de hair.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Mar 2011 (estimated)
- 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.
The aim of this study is to determine the efficacy of transcranial laser therapy applied in automatic noncontact scanning mode for improving functional disability in patients with hemiplegia from ischemic stroke undergoing a rehabilitation program.
Detailed description
Transcranial laser therapy is applied with an InGa(Al)As diode laser.The laser in automatic scanning is applied over both cerebral hemisphere during 15 sessions. Patients simultaneously performed a program of therapeutic exercises 3 days a week. Outcome measures were the Fugl-Meyer Upper Extremity scale, which assessed upper limb motor function, and the Barthel index, which assessed general functional disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial low level laser therapy | Experimental | Procedure: low level laser therapy procedureTranscranial laser therapy is applied by automatic scanning over both hemispheres and the patients undergoing also a standard rehabilitation program based on therapeutic exercises. |
| Control | Active comparator | Procedure: low level laser therapy procedureThe patients undergoing only a standard rehabilitation program based on therapeutic exercises. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with hemiplegia secondary to cerebral stroke ischemic.
- Requirement of shaving the scalp area.
- Initiation of the TLT procedure begins between 70 and 100 days after stroke onset.
- Informed written consent before enrolling in the study.
Key exclusion criteria (4 listed)
- Hemiplegia secondary to hemorrhagic stroke.
- Metallic brain implants.
- Neurodegenerative disorders.
- Bilateral motor problems.
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 |
|---|---|---|
| low level laser therapy procedureAlso: COMBY 3 Terza Serie C-LASER; ASA.Transcranial low level laser therapy by automatic scanning noncontact over both cerebral hemispheres. | Procedure or surgery | Control, Transcranial low level laser therapy |
Primary outcome
Fugl-Meyer Scale
Time frame: 20 minutes
The upper extremity Fugl-Meyer subscale (0-66) considers flexor and extensor synegies as well as reflex activity and coordination and is specific for grading motor impairments.
1 secondary outcome
Barthel index
Time frame: 10 minutes
Results and safety
The study was stopped early (reason given: Based in the negative of patients to shave de hair.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2012.
Related trials for Hemiplegia
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
Active, not recruitingObservational study
Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders
Dystonia, Parkinsonism
RecruitingObservational study
Post-Stroke Apraxia, Motor Function, Balance, and Gait
Stroke, Ideomotor Apraxia
RecruitingObservational study
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
Stroke, Ideomotor Apraxia
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.
Ramón Montes-Molina, PT principal investigator
Hospital University Ramon y Cajal. IRYCIS.Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing low level laser therapy procedure in people with Hemiplegia, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 4 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: stopped early, as of the sponsor's last update on 3 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Based in the negative of patients to shave de hair.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Scale (time frame: 20 minutes). 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 3 Apr 2012.