StrokeNCT01623973
Impact of Restriction of the Non Paretic Upper Limb Rehabilitation of Patients a With Stroke:Randomized Clinical Trial
A study testing specific training of paretic upper limb in people with Stroke, run by Universidade Federal de Pernambuco.
Trial summary
To evaluate whether the restriction of the non paretic upper limb (UL) is a factor that could interfere at the sensorimotor UL recovery for chronic stroke subjects and to verify the impact on daily function, quality of life. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- specific training of paretic upper limb
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to May 2012
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ability to actively extend at least 10° at the metacarpophalangeal the wrist;
- more than 6 months post onset of stroke;
Who cannot join
- Mini-Mental State Examination;
- no excessive spasticity in any joints of the affected.
About this study
Official title: Impact of the Restriction of the Non Paretic Upper Limb in Rehabilitation of Patients Post-stroke:Randomized Clinical Trial
To evaluate whether the restriction of the non paretic upper limb (UL) is a factor that could interfere at the sensorimotor UL recovery for chronic stroke subjects and to verify the impact on daily function, quality of life. In this pilot, randomized, blind and allocation concealment clinical trial, nineteen individuals with chronic stroke was randomly assigned, after the first evaluation, into two groups: group without restriction (G1), subject only to the specific training of paretic UL, and restricted group (G2), which underwent specific training of paretic UL and use of the restriction of non paretic UL
- Conditions
- Stroke
- Being tested
- specific training of paretic upper limb
- Keywords
- hemiparetic, cognitive, balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specific training of paretic upper limbOther
nineteen individuals with chronic stroke was randomly assigned, after the first evaluation, into two groups: group without restriction (G1), subject only to the specific training of paretic UL, and restricted group (G2), which underwent specific training of paretic UL and use of the restriction of non paretic UL. The volunteers were evaluated before the beginning of the interventions, and the next day after completion of the 12 therapy sessions through the Fugl-Meyer Assessment
| Study group | Role | What they receive |
|---|---|---|
| With restraint | Experimental | The group with restraint underwent specific training of paretic upper limb and use of restraint. Receives: Other: specific training of paretic upper limb |
| no restraint | Active comparator | The group control "without restraint" submitted only to the specific training of paretic upper limb Receives: Other: specific training of paretic upper limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the impact that the restriction of non-paretic upper limb recovery would have on sensorimotor with Fugl-Meyer Scale
Upper extremity motor impairment was evaluated using the Fugl-Meyer Assessment Scale (FM).This scale has a total score of 66 points for upper limbs, reflecting a mild motor impairment (≥ 50), moderate to severe (50-20) and severe (< 20).
Measured: 1 year
Secondary outcomes (1)
Functional Independence Measure (FIM)
The FIM consists of 18 items divided into 6 subscales measuring self-care, sphincter control, transfer, locomotion, communication, and social cognition ability. Each item is rated from 1 to 7 based on the required level of assistance to perform the basic ADL (maximum score, 126). Higher scores demonstrate greater independent participation in daily activities.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startMar 2011
- Primary completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciana B. dos Santos, PT, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623973
- Sponsor's protocol ID
- NCI-2012-MDTR, Brazil
- Status last verified
- Jun 2012
- First submitted
- 12 Jun 2012
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Restriction of the Non Paretic Upper Limb in Rehabilitation of Patients Post-stroke:Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01623973
- Acronym / sponsor ID
- NCI-2012-MDTR, Brazil
- Conditions
- Stroke
- Keywords
- hemiparetic, cognitive, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2012 (actual)
- First posted
- 20 Jun 2012 (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.
To evaluate whether the restriction of the non paretic upper limb (UL) is a factor that could interfere at the sensorimotor UL recovery for chronic stroke subjects and to verify the impact on daily function, quality of life. In this pilot, randomized, blind and allocation concealment clinical trial, nineteen individuals with chronic stroke was randomly assigned, after the first evaluation, into two groups: group without restriction (G1), subject only to the specific training of paretic UL, and restricted group (G2), which underwent specific training of paretic UL and use of the restriction of non paretic UL
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With restraint | Experimental | Other: specific training of paretic upper limbThe group with restraint underwent specific training of paretic upper limb and use of restraint. |
| no restraint | Active comparator | Other: specific training of paretic upper limbThe group control "without restraint" submitted only to the specific training of paretic upper limb |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ability to actively extend at least 10° at the metacarpophalangeal the wrist;
- more than 6 months post onset of stroke;
Key exclusion criteria (2 listed)
- Mini-Mental State Examination;
- no excessive spasticity in any joints of the affected.
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 |
|---|---|---|
| specific training of paretic upper limbnineteen individuals with chronic stroke was randomly assigned, after the first evaluation, into two groups: group without restriction (G1), subject only to the specific training of paretic UL, and restricted group (G2), which underwent specific training of paretic UL and use of the restriction of non paretic UL. The volunteers were evaluated before the beginning of the interventions, and the next day after completion of the 12 therapy sessions through the Fugl-Meyer Assessment | Other | With restraint, no restraint |
Primary outcome
To investigate the impact that the restriction of non-paretic upper limb recovery would have on sensorimotor with Fugl-Meyer Scale
Time frame: 1 year
Upper extremity motor impairment was evaluated using the Fugl-Meyer Assessment Scale (FM).This scale has a total score of 66 points for upper limbs, reflecting a mild motor impairment (≥ 50), moderate to severe (50-20) and severe (< 20).
1 secondary outcome
Functional Independence Measure (FIM)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing specific training of paretic upper limb in people with Stroke, run by Universidade Federal de Pernambuco.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 20 Jun 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To investigate the impact that the restriction of non-paretic upper limb recovery would have on sensorimotor with Fugl-Meyer Scale (time frame: 1 year). 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 20 Jun 2012.