Robotic Hand Rehabilitation

NCT05983822 | Completed

• 1 other identifier: 0000052/23
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The performance of activities of daily living (ADL) depends to a large extent on the functionality of the upper limb and hand. Stroke is the leading cause of disability worldwide, with a significant individual, family and economic impact. After a stroke event, however, a large percentage of affected patients have a deficit of the hand and, six months after the acute event, 65% of patients with a deficit of the hand are unable to use and integrate the affected hand in activities of daily living, significantly reducing its quality. The impairment of strength, grip and general hand function makes it difficult to perform ADLs and affects the independence of functional activities, making the recovery of hand function an extremely challenging field in stroke rehabilitation.

Conditions

Stroke; Spasticity as Sequela of Stroke; Upper Limb

Keywords

Stroke; Robotic rehabilitation; Upper limb

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment - Upper Extremity (FMA-UE)

  The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is a stroke-specific, performance-based impairment index. Upper Extremity section is designed to assess motor functioning, 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. For each item, a score can be assigned on direct observation of performance. The scale items are scored according to the ability to complete the item using a 3-point ordinal scale where 0=not able to perform, 1=performs partially and 2=performs completely. The motor function macro-area has a maximum total score of 66; the sensitivity macro-area has a maximum total score of 60.

  Change from Baseline FMA-UE at 4 weeks

Secondary Outcomes (11)

• Modified Fatigue Impact Scale (MFIS)

  Change from Baseline MFIS at 4 weeks

• Fatigue Scale for Motor and Cognitive Function (FSMC)

  Change from Baseline FSMC at 4 weeks

• The Medical Research Council (MRC) Scale

  Change from Baseline MRC at 4 weeks

• Motricity Index - Upper Limb (MI-UL)

  Change from Baseline MI-UL at 4 weeks

• Stroke Upper Limb Capacity Scale (SULCS)

  Change from Baseline SULCS at 4 weeks

Study Arms (2)

Experimental Group (GA)

EXPERIMENTAL

The experimental group (GA) will perform specific rehabilitation for the recovery of hand function using the end-effector robot Amadeo® (Tyromotion, Austria) 3 times a week, for 4 weeks (12 total sessions), for 45 minutes of treatment in addition to conventional treatment. In particular, the technological rehabilitation performed using the robot will mostly aim at improving finger mobility and strength, and flexion-extension exercises will be proposed in passive, active assisted and active mode, exercises for improving strength and muscle tone.

Device: Technological Group

Conventional Group (GC)

ACTIVE COMPARATOR

GC patients will undergo conventional rehabilitation treatment only, using the main rehabilitation methods (e.g. neurocognitive theory, progressive neuromuscular facilitation, etc.).

Device: Technological Group; Other: Conventional Treatment

Interventions

Technological Group DEVICE

Specific rehabilitation for the recovery of hand function using the end-effector robot

Also known as: Amadeo® (Tyromotion, Austria)

Conventional Group (GC); Experimental Group (GA)

Conventional Treatment OTHER

Conventional rehabilitation

Conventional Group (GC)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ischaemic or haemorrhagic stroke documented by neuroimaging techniques (magnetic resonance imaging or computed tomography)
• Latency since acute event between 1 and 6 months;
• Cognitive ability to execute simple orders and understand the physiotherapist's instructions, assessed by Token Test (score ≥ 26.5);
• Ability to understand and sign informed consent.

You may not qualify if:

• Presence of a pincer grip "possible against resistance but weaker than the contralateral" as assessed by the Upper Limb Motricity Index ≥ 26;
• Behavioural, cognitive disorders and/or reduced compliance that could interfere with rehabilitation treatment;
• Presence of ankylosis as assessed by the modified Ashworth Scale ≥ 4;
• Inability to discriminate distinctly between images displayed on a monitor placed at eye level of each subject at a distance of approximately 50 cm, even with corrective glasses;
• Inability to provide informed consent.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Silvia Giovannini, MD, phD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  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: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 9, 2023
• Study Start: October 2, 2023
• Primary Completion: April 30, 2024
• Study Completion: October 28, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

IT (1)