Clinical trial NCT04164381: Robotic Rehabilitation and Cognitive Functions
Official title: Use of Robotics to Improve Cognitive Functions in Subject With Subacute Stroke: a Bicentric Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Rehabilitation
Robotics
Cognitive Function
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 51
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A recent multicenter study of the Fondazione Don Gnocchi (FDG) Robotic Rehabilitation Group (NCT02879279) showed the efficacy of robotic rehabilitation in upper limb motor recovery after stroke using a set of robots and sensor-based devices. In clinical practice, beside sensory-motor deficits, stroke patients often present concomitant cognitive impairments (as attention and memory disorders). The robotic and technological systems used in the above-mentioned study allow training on some cognitive functions such as visual memory, visual-spatial functions and working memory, as well as motor training of the upper limb. The aim of the study is to assess whether cognitive functions, such as visual memory, visual-spatial skills and working memory (evaluated with specific tests) improve after robotic therapy of the upper limb in subacute stroke patients.

Detailed description: It is estimated that up to three quarters of acute and subacute stroke survivors exhibit cognitive impairment. Cognitive impairment can significantly compromise functional recovery, quality of life, and social engagement after stroke. Indeed, some authors showed that the impairment of cognitive functions can negatively influence rehabilitation strategies. Robotic therapy has been proposed as a viable approach for the rehabilitation of the upper limb, as a way to increase the amount and intensity of the therapy, and to standardize the treatment, adding a complex but controlled multisensory stimulation to the patient. In fact, owing to the complex training environments, robotic and technological devices may promote the re-learning capacity, inducing functional or structural plasticity in brain networks that control both motor and cognitive functions. Our hypothesis is that the cognitive engagement of patients during upper limb robotic therapy can impact on some cognitive functions that are compromised after the stroke.

The current pilot study aims to evaluate the effects of an upper limb robotic rehabilitation treatment on cognitive functions in patients with subacute stroke.

Fifty consecutive patients with sub-acute stroke (within 6 months of the event) will be enrolled in two rehabilitation centers.

All patients will perform a robotic treatment of the upper limb (30 sessions, 5 times a week) using a set of robotic devices. The training will include motor-cognitive exercises specifically selected to train spatial attention, vision and working memory, praxis, executive functions, and speed of processing. Furthermore, patients will undergo a comprehensive rehabilitation program including individual conventional physiotherapy (6 times/week), lasting 45 minutes focused on lower limb, sitting and standing training, balance and walking.

Subjects will be evaluated at baseline (T0) and after treatment (T1). To be included in the analysis, patients will have to undergo at least 25 rehabilitation sessions, without interrupting the treatment (due to clinical complications) for more than six consecutive sessions; otherwise, they will be considered as dropouts.

The effects of the rehabilitation intervention on the upper limb function and disability will be assessed with the following clinical scales: Fugl-Meyer Assessment for Upper Extremity (FMA), to evaluate motor function; the Motricity Index (MI), to evaluate muscle strength; the Modified Barthel Index (mBI), to evaluate activities of daily living (ADL) and mobility.

Oxford Cognitive Screen (OCS) will be performed as screening tool to evaluate cognitive functions. Moreover, the following cognitive tests will be used: 1) Digit Span (attention/short-term memory involving strings/series of digits of varying length); 2) Tower of London (planning and problem solving); 3) STROOP test (Stroop Color and Word Test); 4) Symbol Digit Modalities Test (processing speed of visual stimuli); 5) Rey-Osterrieth Complex Figure Test (ROCF) (visuomotor integration).

Eligibility criteria: Inclusion Criteria:

* first ischemic or hemorrhagic stroke (verified by MRI or CT);
* time latency within 6 months from stroke (subacute patients);
* age between 35-85 years;
* cognitive abilities adequate to understand the experiments and the follow instructions Token test ≥26.5 (correction as for age and school level);
* upper limb impairment (FMA score ≤58);
* ability to give written consent;
* compliance with the study procedures.

Exclusion Criteria:

* history of recurrent stroke;
* inability to understand the instructions required for the study;
* fixed contraction in the affected limb (ankylosis, Modified Ashworth Scale equal to 4);
* severe deficits in visual acuity.

Primary outcomes:
measure: Change in Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
Secondary outcomes:
measure: Tower of London (TOL)
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: Change in Rey-Osterrieth Complex Figure Test (ROCF).
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: Change in Digit Span (DS)
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: Change in Stroop and Color Word test (SCWT)
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
Other outcomes:
measure: Change in Motricity Index (MI)
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: Change in Modified Barthel Index (BI)
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: Change in Fugl-Meyer Assessment of Motor Recovery after Stroke for Upper Extremity portion (FMA-UL)
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
Locations:
city: Rome
country: Italy
facility: Don Gnocchi Foundation
Study officials:
affiliation: Fondazione Don Carlo Gnocchi Onlus
name: Irene Aprile, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aprile I, Germanotta M, Cruciani A, Loreti S, Pecchioli C, Cecchi F, Montesano A, Galeri S, Diverio M, Falsini C, Speranza G, Langone E, Papadopoulou D, Padua L, Carrozza MC; FDG Robotic Rehabilitation Group. Upper Limb Robotic Rehabilitation After Stroke: A Multicenter, Randomized Clinical Trial. J Neurol Phys Ther. 2020 Jan;44(1):3-14. doi: 10.1097/NPT.0000000000000295.
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citation: Faria AL, Cameirao MS, Couras JF, Aguiar JRO, Costa GM, Bermudez I Badia S. Combined Cognitive-Motor Rehabilitation in Virtual Reality Improves Motor Outcomes in Chronic Stroke - A Pilot Study. Front Psychol. 2018 May 30;9:854. doi: 10.3389/fpsyg.2018.00854. eCollection 2018.
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citation: Aprile I, Guardati G, Cipollini V, Papadopoulou D, Mastrorosa A, Castelli L, Monteleone S, Redolfi A, Galeri S, Germanotta M. Robotic Rehabilitation: An Opportunity to Improve Cognitive Functions in Subjects With Stroke. An Explorative Study. Front Neurol. 2020 Nov 19;11:588285. doi: 10.3389/fneur.2020.588285. eCollection 2020.