Acute Stroke Clinical Trial
Official title:
Study of the Effectiveness of an Interactive Robot for the Rehabilitation of the Upper Limb in Acute Stroke Patients by Evaluating the 3 Fields of the ICF: a Prospective, Randomized, Controlled, Simple Blind Study
Verified date | August 2018 |
Source | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Stroke is the principal cause of permanent disability within the investigators population.
This incapacity justifies an intensive and prolonged multidisciplinary rehabilitation, which
can be optimized by robotics.
The investigators team has developed a robot designed to rehabilitate the upper limb. This
robot allows the patient to perform active, passive, or assisted exercises. The system is
also able to assess movement quality and to provide a feedback to the patient and the
therapist via a graphical interface. This therapy is designed to improve functional recovery
of patients, and then their quality of life.
Few quality studies have evaluated the efficacy of robotic assisted therapy in patients at
the acute stage of rehabilitation (< 3 months post stroke) when most improvements are
observed.
Thus, the aim of this study was to objectify the effectiveness of robotic-assisted
rehabilitation in the acute stage after stroke by evaluating the 3 fields of the ICF
(International Classification of Functioning, Disability and Health) and performing a
prospective multicenter randomized controlled single blind trial. In this study, 60 stroke
patients will be recruited and randomized into two groups. All patients will receive a
similar classical rehabilitation as a basis. Patients of the control and experimental groups
will receive a supplement of classical rehabilitation and robotic-assisted therapy,
respectively.
Status | Completed |
Enrollment | 45 |
Est. completion date | October 2, 2017 |
Est. primary completion date | January 9, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - first stroke - acute stroke (less than 1 month) - unilateral localisation of the stroke - moderate to severe upper limb impairments (7<Fugl Meyer score<50/66) Exclusion Criteria: - brainstem or cerebellum stroke - an unstable clinical condition contraindicating the upper limb rehabilitation treatments - cognitive disorders preventing the understanding of the instructions - other neurological or orthopedic pathology affecting the upper limb |
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques Universitaires Saint Luc | Brussel | |
Belgium | Centre Hospitalier Valida | Bruxelles | |
Belgium | Centre Neurologique William Lennox | Ottignies |
Lead Sponsor | Collaborator |
---|---|
Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
Belgium,
Duncan PW, Zorowitz R, Bates B, Choi JY, Glasberg JJ, Graham GD, Katz RC, Lamberty K, Reker D. Management of Adult Stroke Rehabilitation Care: a clinical practice guideline. Stroke. 2005 Sep;36(9):e100-43. — View Citation
Gilliaux M, Lejeune TM, Detrembleur C, Sapin J, Dehez B, Selves C, Stoquart G. Using the robotic device REAplan as a valid, reliable, and sensitive tool to quantify upper limb impairments in stroke patients. J Rehabil Med. 2014 Feb;46(2):117-25. doi: 10.2340/16501977-1245. — View Citation
Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5. Review. — View Citation
Mehrholz J, Hädrich A, Platz T, Kugler J, Pohl M. Electromechanical and robot-assisted arm training for improving generic activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD006876. doi: 10.1002/14651858.CD006876.pub3. Review. Update in: Cochrane Database Syst Rev. 2015;(11):CD006876. — View Citation
Pignolo L. Robotics in neuro-rehabilitation. J Rehabil Med. 2009 Nov;41(12):955-60. doi: 10.2340/16501977-0434. — View Citation
Stinear CM, Barber PA, Petoe M, Anwar S, Byblow WD. The PREP algorithm predicts potential for upper limb recovery after stroke. Brain. 2012 Aug;135(Pt 8):2527-35. doi: 10.1093/brain/aws146. Epub 2012 Jun 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Kinematic | Change from Baseline in Kinematic at an expected average of 2 months (after the treamtment) and 6 months post stroke | ||
Secondary | Fugl-Meyer upper limb assessment | Change from Baseline in upper limb motor control at an expected average of 2 months (after the treamtment) and 6 months post stroke | ||
Secondary | Stroke Impairment Assessment Set (sensitive and Pain items) | Change from Baseline in sensitivity and pain at an expected average of 2 months (after the treamtment) and 6 months post stroke | ||
Secondary | Box and Block test | Change from Baseline in manual ability at an expected average of 2 months (after the treamtment) and 6 months post stroke | ||
Secondary | Strenght test of the Medical Research council | Change from Baseline in upper limb strenght at an expected average of 2 months (after the treamtment) and 6 months post stroke | ||
Secondary | Ashworth test | Change from Baseline in upper limb spasticity at an expected average of 2 months (after the treamtment) and 6 months post stroke | ||
Secondary | Bell's test | Change from Baseline in Hemineglect at an expected average of 2 months (after the treamtment) and 6 months post stroke | ||
Secondary | Wolf Motor Function Test | Change from Baseline in activity of daily living at an expected average of 2 months (after the treamtment) and 6 months post stroke | ||
Secondary | Abilhand | Change from Baseline in activity of daily living at an expected average of 2 months (after the treamtment) and 6 months post stroke | ||
Secondary | Activlim | Change from Baseline in activity of daily living at an expected average of 2 months (after the treamtment) and 6 months post stroke | ||
Secondary | Stroke Impact Scale (Participation item) | Change from Baseline in participation in social activities at an expected average of 2 months (after the treamtment) and 6 months post stroke |
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