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Stroke RehabilitationPost AVC-AVQNCT03118648

Recovery of Upper Limb Paresis at Discharge After Stroke and Its Level of Use in Activities of Daily Living 3 to 6 Months Later (Post AVC-AVQ)

An observational study of Stroke Rehabilitation, run by University Hospital, Bordeaux at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim is to reduct spontaneous use an activities of daily living of the paretic upper limb after stroke i six months after patient discharge from rehabilitation center. The level of functional recovery at rehabilitation discharge could better guide rehabilitation strategies to enhance independence and participation… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke Rehabilitation
What is being tested?
Scale Action Research Arm Test (ARAT)
Type of treatment
Pill or oral medicine
How many people
192 participants
Where
1 siteFrance
Study dates
1 Jul 2017to 1 Jun 2020
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients eligible to participate in the study will be adults who have experienced a first stroke and are about to leave the rehabilitation facility for their home. These people should have a good oral comprehension. They must not have a psychiatric history with hospitalization of more than 6 months. They must have been independent in the activities of daily life before their stroke. They must be affiliated to a social security scheme, be willing to participate in the study and not participate in another research.

Who may be able to join

  • Patients over 18 years old leaving the correctional institution with orientation back home
  • First stroke deficit with non-regressive clinical expression in 24 hours
  • Independent in activities of daily living and living at home and daily activities independence before the stroke. This earlier independence is confirmed by the absence of professional carers in personal care activities (yes / no)
  • Proper oral understanding as measured by score 7 in the language screening test LAST (Flamand-Roze et al, 2011)
  • No psychiatric history that led to hospitalization for more than six months
  • Patient has given its consent within the period provided after reading the briefing note
  • Patient affiliated or beneficiary of a social security scheme.

Who cannot join

  • Lack of minimum functional motor recovery in paretic upper limb allowing the patient to go put hand to his mouth and to realize do a 45 degrees abduction with the paretic upper limb.
  • Barthel Index score (BI) less than or equal to 40. It is suggested in the literature that a score less than or equal to 40 is a key score of total dependence
  • Persistent severe hemineglect (bells test score > 6).

Trial locations and contacts

1 site in 1 country.

Eric SORITA, PhD contact

+33557820967

eric.sorita@chu-bordeaux.fr

France1 site

  • Bordeaux University Hospital

    Bordeaux

    Eric SORITA, PhD, +33557820967, eric.sorita@chu-bordeaux.fr

    Eric SORITA, PhD

Other trials in France

About this study

Official title: Relations Between the Level Upper Limb Paresis Recovery in Output of the Hospital Unit Continued Care and Rehabilitation and Its Level of Use in Lifestyle at Three and Six Months

The aim is to reduct spontaneous use an activities of daily living of the paretic upper limb after stroke i six months after patient discharge from rehabilitation center. The level of functional recovery at rehabilitation discharge could better guide rehabilitation strategies to enhance independence and participation in daily life.

This study aims to determine, in patients after stroke, the optimal affected upper limb recovery threshold at rehabilitation discharge to predict spontaneous level of use of affected upper limb in activities of daily living, six month later.

This study is a multicentric prognostic prospective cohort study. The main prognostic variable will be the Action Arm Test (ARAT, Lyle, 1981) score at rehabilitation discharge and the predicted variable will be the Motor Activity Log - 28 (Taub et al. 1993) score at 6 months post discharge.

Read the detailed description

Adults after stroke will be recruited at post-acute rehabilitation discharge. Three evaluation times will be undertaken: at discharge, three and six months after discharge. Evaluation battery will focus on the three level of the Functioning International Classification: affected upper limb level of strength, proprioception and level of functional recovery, hemineglect, depression, cognition status, and activity level by doing a standardised instrumental task of daily living, and level of participation questionnaire. General characteristics will be taken into account: Age, social status, laterality.

At six months, the spontaneous level of affected upper arm use in daily living will also be assessed using accelerometers.

As the main aim of the study is to build a prediction model, the study size is calculated to observe a minimal number of events by potentially predictive variable. We consider here 7.5 events by independent variable (Vittinghof and McCulloch, 2007) and eight independent variables. According to literature review, we estimated that 35% of adults included in this study would spontaneously use their affected upper arm in activities of daily living six months after discharge. According to these data and considering 10% of protocol deviations, we calculated that 192 subjects will have to be included in the study. The inclusion duration will be 30 months.

Being tested
Scale Action Research Arm Test (ARAT)
Keywords
upper limb, functional recovery, activities of daily living

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Scale Action Research Arm Test (ARAT)Diagnostic test

    Measuring the functional recovery of the paretic upper limb rehabilitation outing with the scale ARAT

Study groups in NCT03118648
Study groupRoleWhat they receive
stroke* Patients over 18 years old leaving the correctional institution with orientation back home * First stroke deficit with non-regressive clinical expression in 24 hours * Independent in activities of daily living and living at home before stroke. This earlier independence is confirmed by the absence of professional carers in personal care activities * Proper oral understanding as measured by score 7 in the Language Screening Test (LAST) (Flamand-Roze et al, 2011) * No psychiatric history that led to hospitalization for more than six months * Written informed consent after reading the briefing note * Patient affiliated or beneficiary of a social security scheme.
Receives: Diagnostic Test: Scale Action Research Arm Test (ARAT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Motor Activity

    Score of Motor Activity Log scale

    Measured: Month 6

Secondary outcomes (12)

  1. Action Arm

    Score of Action Research Arm Test scale

    Measured: Day 0

  2. Action Arm

    Score of Action Research Arm Test scale

    Measured: Day 180

  3. Cognitive abilities

    Score with kettle test

    Measured: Day 0

  4. Cognitive abilities

    Score with kettle test

    Measured: Day 180

  5. "Mesure des HAbitudes de VIE" (MHAVIE)

    Score of "Mesure des HAbitudes de VIE" scale (MHAVIE)

    Measured: Day 0

  6. "Mesure des HAbitudes de VIE" (MHAVIE)

    Score of "Mesure des HAbitudes de VIE" scale (MHAVIE)

    Measured: Day 180

  7. "Montreal Cognitive Assessment" (MoCA)

    Score of "Montreal Cognitive Assessment" (MoCA)

    Measured: Day 0

  8. "Montreal Cognitive Assessment" (MoCA)

    Score of "Montreal Cognitive Assessment" (MoCA)

    Measured: Day 180

  9. Aphasic Depression Rating (ADRS)

    Score of Aphasic Depression Rating Scale (ADRS)

    Measured: Day 0

  10. Aphasic Depression Rating (ADRS)

    Score of Aphasic Depression Rating Scale (ADRS)

    Measured: Day 180

  11. Unilateral spatial neglect (NSU) in the vicinity of extrapersonal space

    Score of "Bell test (test de barrage des cloches)"

    Measured: Day 0

  12. Unilateral spatial neglect (NSU) in the vicinity of extrapersonal space

    Score of "Bell test (test de barrage des cloches)"

    Measured: Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2017
  2. Study start1 Jul 2017 (estimated)
  3. Primary completion1 Jun 2020 (estimated)
  4. Study completion1 Jun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
192 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03118648
Sponsor's protocol ID
CHUBX2015/24
Acronym
Post AVC-AVQ
Status last verified
Jun 2017
First submitted
13 Apr 2017
Last updated
22 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available.

    PubMed 7333761

  • Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.

    PubMed 8466415

  • Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007 Mar 15;165(6):710-8. doi: 10.1093/aje/kwk052. Epub 2006 Dec 20.

    PubMed 17182981

  • Uswatte G, Giuliani C, Winstein C, Zeringue A, Hobbs L, Wolf SL. Validity of accelerometry for monitoring real-world arm activity in patients with subacute stroke: evidence from the extremity constraint-induced therapy evaluation trial. Arch Phys Med Rehabil. 2006 Oct;87(10):1340-5. doi: 10.1016/j.apmr.2006.06.006.

    PubMed 17023243

  • Veerbeek JM, Kwakkel G, van Wegen EE, Ket JC, Heymans MW. Early prediction of outcome of activities of daily living after stroke: a systematic review. Stroke. 2011 May;42(5):1482-8. doi: 10.1161/STROKEAHA.110.604090. Epub 2011 Apr 7.

    PubMed 21474812

  • Rand D, Eng JJ. Predicting daily use of the affected upper extremity 1 year after stroke. J Stroke Cerebrovasc Dis. 2015 Feb;24(2):274-83. doi: 10.1016/j.jstrokecerebrovasdis.2014.07.039. Epub 2014 Dec 18.

    PubMed 25533758

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke Rehabilitation, run by University Hospital, Bordeaux at 1 site in France.

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 7 inclusion and 3 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 22 Jun 2017. 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 France. 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.

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 Eric SORITA, PhD (+33557820967, eric.sorita@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Motor Activity (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03118648, which also lists 6 linked publications.

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 22 Jun 2017.

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