A Randomized Controlled Multicenter Study on the Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- IRCCS San Raffaele Roma
- Enrollment
- 70
- Locations
- 7
- Primary Endpoint
- Change in Fugl-Meyer Assessment of Upper Extremities motor recovery after stroke -FMA
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
Loss of arm function is a common and distressing consequence of stroke. Neurotechnology-aided rehabilitation could be a promising approach to accelerate the recovery of upper limb functional impairments. This multicentre randomized controlled trial is aimed at assessing the efficacy of robot-assisted upper limb rehabilitation in subjects with sub-acute stroke following a stroke, compared to the traditional upper limb rehabilitation.
Detailed Description
Stroke is the most common cause of complex adult disability in high-income countries \[1\]. Loss of arm function affects 69% of people who have a stroke \[2\]. Only 12% of people with arm weakness at the onset of stroke make a full recovery \[3\]. Improving arm function has been identified as a research priority by stroke survivors, carers, and health professionals who report that current rehabilitation pays insufficient attention to arm recovery \[4\]. Robot-assisted training enables a greater number of repetitive tasks to be practiced in a consistent and controllable manner. Repetitive task training is known to drive Hebbian plasticity, where the wiring of pathways that are coincidently active is strengthened \[5, 6\]. A dose of greater than 20 h of repetitive task training improves upper limb motor recovery following a stroke \[7\] and, therefore, robot-assisted training has the potential to improve arm motor recovery after stroke. We anticipate that Hebbian neuroplasticity, which is learning dependent, will operate regardless of the post-stroke phase. We, hereby, describe the protocol for a multicentre randomized controlled trial to determine whether robot-assisted training improves upper limb function following a stroke in the sub-acute stage.
Investigators
Eligibility Criteria
Inclusion Criteria
- •age between 18 and 85 years;
- •first stroke with neurological outcomes affecting the upper limb;
- •patients with severe or moderate hemiparesis (FM-UL≤44), stratified according to severe (FM-UL ≤ 22) or moderate (22 \<FM-UL ≤ 44) motor deficit;
- •patients in the sub-acute phase within 90 days of the acute event, stratified by the distance from the acute event (OAI≤30; OAI\> 30);
- •Modified Ashworth Scale (MAS) of the main components (shoulder, elbow, and wrist) of the upper limb \<3;
- •sufficient cognitive and linguistic level to understand the instructions and provide consent;
- •signed informed consent.
Exclusion Criteria
- •unstable general clinical conditions;
- •severe visual impairment;
- •inability to maintain the sitting position;
- •mild motor deficit of the arm (FM-UL\> 44) at baseline;
- •recent botox injection in the upper limb or planned botox injection during the study period, including the follow-up;
- •inability to don the orthosis on the impaired upper limb;
- •bone instability in relevant areas of the upper extremity (unconsolidated fractures, fractures due to osteoporosis);
- •fixed contractures involving the impaired upper limb (e.g. frozen shoulder);
- •shoulder instability;
- •severe pain syndromes caused or intensified by rehabilitation with Armeo Power;
Outcomes
Primary Outcomes
Change in Fugl-Meyer Assessment of Upper Extremities motor recovery after stroke -FMA
Time Frame: Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. In this study, we will consider the motor performance items of Upper extremity (0-66), only.
Secondary Outcomes
- Change in Modified Ashworth Scale (shoulder, elbow, and wrist).(Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).)
- Change in Box & Block Test(Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).)
- Change in Nine Hole Peg Test(Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).)
- Change in Frenchy Arm Test(Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).)
- Change in modified Barthel Index(Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).)
- Change in Modified Rankin scale(Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).)