Recruiting

Impairment-Specific Treatment

Sponsor:

University of Maryland, Baltimore

Code:

NCT02359253

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Passive stretching

Passive movement

IntelliArm

Hand robot

Study Details

Brief summary:

Sensorimotor impairments following stroke often involve complex pathological changes across multiple joints and multiple degrees of freedom of the arm and hand, thereby rendering them difficult to diagnose and treat. The objective of this study is to evaluate multi-joint neuromechanical impairments in the arm and hand, then conduct impairment-specific treatment, and determine the effects of arm versus hand training and the effects of passive stretching before active movement training.

Conditions

Stroke

Study ID

NCT02359253

Start date

Oct 14, 2018

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • First focal unilateral lesion, ischemic or hemorrhagic
  • Had a stroke 1-12 months prior to enrollment
  • Rated between stages 2-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Arm and Hand

Exclusion Criteria:

  • Apraxia
  • Score of less than 22 on the Mini Mental Status Exam
  • Severe pain in the shoulder by a self-rating of 7 out of 10 or greater
  • Severe contracture in the upper extremity
  • Unable to sit in a chair for 3 consecutive hours
  • Unrelated musculoskeletal injuries
  • Poor fit into equipment used in study
  • Botox injection in upper extremity within 4 months
  • Concurrent participation in gait or upper extremity intervention studies

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IntelliArm with passive stretching

Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of strong passive stretching, then followed by 45-60 minutes of active movement training with the IntelliArm.

experimental: IntelliArm with passive movement

Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the IntelliArm for up to 30 minutes with gentle passive movement or little stretching, then followed by 45-60 minutes of active movement training with the IntelliArm.

experimental: The hand robot with passive stretching

Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of strong passive stretching, then followed by 45-60 minutes of active movement training with the hand robot.

experimental: The hand robot with passive movement

Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the hand robot for up to 30 minutes with gentle passive movement or little stretching, then followed by 45-60 minutes of active movement training with the hand robot.

Interventions

Passive stretching

Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot within preset ranges of motion.

Passive movement

Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot only within ranges that produce no to very minimal forces.

IntelliArm

During the active training, subjects will be asked to actively move their arm while supported with IntelliArm robot to interact with virtual targets and objects. The IntelliArm may provide resistance or assistance.

Hand robot

During the active training, subjects will be asked to actively open and close their hand with the hand robot on while participating in task oriented occupational therapy focused on grasp and release tasks. The hand robot may provide resistance or assistance.

Primary outcome measure

  • Changes from baseline Graded Wolf Motor Function Test (WMFT) at two time points [ Time Frame: Within 2 week prior to intervention, 2 week following intervention, and 2 months following intervention ]

Central Contacts and Locations

Central contacts

Soh-Hyun Hur

(410) 706-1625sohur@som.umaryland.edu

Kyung Koh, Ph.D.

(410) 706-8625KKoh@som.umaryland.edu

Locations

University of Maryland, Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Sanjana Rao, OT

410-706-4546Sanjana.rao@som.umaryland.edu

Kyung Koh, Ph.D.

(410) 706-8625KKoh@som.umaryland.edu

Principal Investigator:

Li-Qun Zhang, Ph.D.

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Stroke
  • Spasticity
  • Arm
  • Hand
  • Robotic therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-09-01.