Recruiting

Robot-Assisted Rehabilitation

Sponsor:

Spaulding Rehabilitation Hospital

Code:

NCT04851886

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BURT

BURT + PostureCheck

Study Details

Brief summary:

The overall objective of this study is to assess whether robot-assisted upper-limb group rehabilitation can be effectively delivered by using a camera-based system equipped with machine learning algorithms to track the quality of the exercise performance and provide feedback accordingly. To address this question, we plan to carry out a randomized clinical trial to compare outcomes in subjects receiving robot-assisted upper-limb rehabilitation during individual (i.e., one-on-one) sessions and in subjects receiving robot-assisted upper-limb rehabilitation during group (i.e., up to three subjects) sessions.

Conditions

Stroke

Study ID

NCT04851886

Start date

Apr 26, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have had a history of ischemic cerebrovascular accident (CVA) within middle cerebral artery (MCA) or anterior cerebral artery (ACA) territory
  • CVA occurred between six months and six years ago
  • Moderate to severe UE impairment, FMA-UE score between 15 and 45
  • Mini-Mental State Examination (MMSE) score >23 and being able to safely follow three-step commands

Exclusion Criteria:

  • Advanced musculoskeletal pathology or recent fractures in the impaired UE
  • Previous diagnosis of neurological diseases other than stroke
  • Severe limitation of passive range of motion or spasticity (Modified Ashworth Scale for spasticity at <3 for UE muscles)
  • Hemorrhagic CVA or involvement of the posterior cerebral artery
  • Aphasia sufficient to limit ability to express needs or discomfort verbally or non-verbally
  • Impaired visual acuity (Severe visual impairments as assessed by the NIH Stroke Scale Visual Field subscale. (score >0))
  • Severe hemispatial neglect as assessed by the Line Bisection Test (score >2)
  • Severely impaired trunk control (<4)
  • Individuals who present with the following on the intended limb:
  • Open wounds
  • Fragile skin
  • Under contact precautions due to an active infection
  • Participation in another therapy focused on recovery of the impaired arm
  • Subjects with cardiac pacemakers, electronic pumps or any other implanted medical devices, that are not US-certified
  • Any Condition that would prevent safe use of the Burt system; such as proprioceptive deficits that impair the ability to process haptic or visual feedback, or unstable shoulder joint as assessed by physical examination
  • Current pregnancy (self-report)
  • The concern is strictly towards women who are in the 2nd or 3rd trimester and the eventuality of the arm of the BURT accidentally impacting the woman's belly. The system does have safety features (including a virtual safety wall, to keep the device away from the patient's body) but we are taking this as an extra precaution against any potential harm

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Individual robot-assisted upper-limb rehabilitation

Participants randomized to this arm of the study will undergo 18 sessions of robot-assisted upper-limb rehabilitation. During the sessions, a therapist will administer one-on-one therapy (i.e. each study volunteer will work with a single therapist).

experimental: Group robot-assisted upper-limb rehabilitation

Participants randomized to this arm of the study will also undergo 18 sessions of robot-assisted upper-limb rehabilitation. However, a therapist will administer the intervention as group therapy with up to three subjects participating in the session at the same time. To facilitate the deliver of the therapeutic intervention, the robot will be equipped with a camera system (called PostureCheck) designed to track the quality of the exercises.

Interventions

BURT

Robot-assisted upper-limb individual (i.e. one-on-one) rehabilitation will be delivered using the BURT system by Barrett Technology

BURT + PostureCheck

Robot-assisted upper-limb group (i.e. up to three subjects) rehabilitation will be delivered using the BURT system by Barrett Technology + PostureChek (a camera-based system to track the quality of the exercises)

Primary outcome measure

  • Change from baseline Fugl-Meyer Assessment - Upper Extremity (FMA-UE) at 7-8 weeks [ Time Frame: Data will be collected at baseline and at 7-8 weeks ]

Central Contacts and Locations

Central contacts

Daniel Tabb, PT

6179526388dtabb1@mgb.org

Federico Bauducco, MS

6179526388fbauducco@mgb.org

Locations

Spaulding Rehabilitation Hospital

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

Daniel Tabb, PT

617-952-6388dtabb1@mgb.org

Federico Bauducco, MS

617-952-6388fbauducco@mgb.org

Principal Investigator:

Paolo Bonato, PhD

More Information

Sponsor

Spaulding Rehabilitation Hospital

Last update posted

Apr 2, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital on 2026-04-02.