Efficacy Study of an Interactive Robot for the Rehabilitation of the Upper Limb in Acute Stroke Patients

NCT02079779 | Completed DMC

• 1 other identifier: IONS-Gilliaux-02
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Acute Stroke

Keywords

Robotic-assisted therapy; Acute Stroke; International Classification of Functioning, Disability and Health

Outcome Measures

Primary Outcomes (1)

• Kinematic

  Change from Baseline in Kinematic at an expected average of 2 months (after the treamtment) and 6 months post stroke

Secondary Outcomes (10)

• 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

• 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

• 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

• 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

• Ashworth test

  Change from Baseline in upper limb spasticity at an expected average of 2 months (after the treamtment) and 6 months post stroke

Study Arms (2)

Robotic-assisted therapy

EXPERIMENTAL

All patients will receive a similar classical rehabilitation as a basis. The 30 patients of this group will receive a supplement of robotic-assisted therapy.

Other: Robotic-assisted therapy; Other: Classical therapy

Classical therapy

ACTIVE COMPARATOR

All patients will receive a similar classical rehabilitation as a basis. The 30 patients of this group will receive a supplement of classical rehabilitation.

Other: Classical therapy

Interventions

Robotic-assisted therapy OTHER

The robotic device is designed to intensively rehabilitate the upper limb. Indeed, this robot allows the patient to perform a lot of active, passive, or assisted exercises. The level of assistance is determined and provided by the robot in function of the patient performance (i.e. quality of movements).

Robotic-assisted therapy

Classical therapy OTHER

Conventional therapy will be performed by therapists specialized in neuro-rehabilitation

Classical therapy; Robotic-assisted therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (3)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

Centre Hospitalier Valida

Brussels, Belgium

Location

Centre Neurologique William Lennox

Ottignies, 1340, Belgium

Location

Related Publications (6)

• 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. doi: 10.1161/01.STR.0000180861.54180.FF. No abstract available.

  PMID: 16120836 BACKGROUND

• Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.

  PMID: 21571152 BACKGROUND

• Mehrholz J, Hadrich 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.

  PMID: 22696362 BACKGROUND

• Pignolo L. Robotics in neuro-rehabilitation. J Rehabil Med. 2009 Nov;41(12):955-60. doi: 10.2340/16501977-0434.

  PMID: 19841823 BACKGROUND

• 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.

  PMID: 22689909 BACKGROUND

• 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.

  PMID: 24213596 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Maxime Gilliaux, PhD student

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

• Gaetan Stoquart, Professor

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

• Christine Detrembleur, Professor

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 6, 2014
• Study Start: January 9, 2015
• Primary Completion: January 9, 2015
• Study Completion: October 2, 2017
• Last Updated: August 24, 2018

Record last verified: 2018-08

Locations

BE (3)