Robotic Rehabilitation and Cognitive Functions

Study Overview
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Brief Summary
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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
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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).

Official Title
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Use of Robotics to Improve Cognitive Functions in Subject With Subacute Stroke: a Bicentric Pilot Study

Conditions
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Stroke

Intervention / Treatment
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* Device: Robotic assisted intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic assisted intervention<br>Upper limb robotic therapy using a set of robotic and sensor based devices and exercises specifically selected to train cognitive functions. | Device: Robotic assisted intervention<br>* Robotic treatment of the upper limb (30 sessions, 5 times a week) using a set of 4 robotic devices: Motore (Humanware); Amadeo, Diego, Pablo (Tyromotion). The training will include motor-cognitive exercises specifically selected to train spatial attention, vision and working memory, praxis, executive function, and speed of processing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Symbol Digit Modalities Test (SDMT) | SDMT evaluates information processing speed. It consists of a simple task of replacing symbols with numbers. Using a reference key, the patient has 90 seconds to match a sequence of symbols with the correspondent numbers as rapidly as possible. Both written or oral administration can be used. For each correct answer, a point is assigned. | Baseline (T0), Treatment (6 weeks) (T1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tower of London (TOL) | The TOL test is a tool to assess strategic decision and problem solving. The patient is required to move different colored balls on the three pegs of different lengths, according to a model and a number of established moves. The maximum time for each configuration is 60 seconds. | Baseline (T0), Treatment (6 weeks) (T1) | 
| Change in Rey-Osterrieth Complex Figure Test (ROCF). | The ROCF is a neuropsychological assessment for evaluation of visuospatial abilities, memory, attention, planning, working memory and executive functions. The patient is required to copy a complex figure freehand (recognition), and then draw it from memory (recall). The score is assigned based on the correctness of each line (from 0 to 2). | Baseline (T0), Treatment (6 weeks) (T1) | 
| Change in Digit Span (DS) | The DS is a test that measures the verbal memory span (digit memory). The patient is required to correctly repeat the sequence of number listened. It is composed by two different tests: the Digits Forward and the Digit Backward. The range for Digit Forward is from 6 to -1. | Baseline (T0), Treatment (6 weeks) (T1) | 
| Change in Stroop and Color Word test (SCWT) | The SCWT is a neuropsychological test used to assess the cognitive interference. The patient is required to read three different tables as fast as possible (in 30 seconds): the first contains 100 names of colors ink in black; the second contains 100 shapes of different colors (red, blue, green); the third contains 100 color-words are printed in an inconsistent color ink (for instance the word red is printed in green ink). | Baseline (T0), Treatment (6 weeks) (T1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Robotics, Cognitive Function