Recruiting

Observational Study

Sponsor:

University of Maryland, Baltimore

Code:

NCT02359812

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

Sensory and motor impairments following stroke can lead to substantial disability involving the arm and hand. The investigator hypothesized that excessive local and cross-coupled stiffness, diminished individuation and proprioceptive acuity will be present among multiple degree of freedom in the upper limb. The stiffness and spasticity will increase with time post-stroke. The objective of this study is to quantify the progression throughout the arm and hand during recovery from stroke. The investigator will measure the clinical assessment scores, and neuromechanical properties including range of motion, active and passive cross coupling, and spasticity by the IntelliArm robot.

Conditions

Stroke

Study ID

NCT02359812

Start date

May 7, 2018

Status verified date

Aug, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. First focal unilateral lesion, ischemic or hemorrhagic
2. Had a stroke less than a month prior to enrollment
3. Rated between stages 1-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Arm
4. Rated between stages 1-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Hand

Exclusion Criteria:

1. Apraxia
2. Other unrelated or musculoskeletal injuries
3. Unable to sit in a chair for 3 consecutive hours
4. Score of less than 22 on the Mini Mental Status Exam
5. Poor fit into equipment used in study which compromises proper use. This will be determined by the judgment of study staff

Study Design

Enrollment

56 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy

Healthy volunteers with no history of neurological disorders

Stroke

Patients had a recent stroke, two weeks or earlier prior to enrollment

Primary outcome measure

  • Changes from baseline Graded Wolf Motor Function Test (WMFT) at six time points [ Time Frame: 2 week (baseline), 1 month, 2 month, 3 month, 4 month, 5 month and 6 month post stroke ]

Central Contacts and Locations

Central contacts

Soh-Hyun Hur, B.S.

(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

Soh-Hyun Hur

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

Kyung Koh, Ph.D.

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

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Stroke
  • Upper extremity
  • Rehabilitation
  • Robot
  • Hemiplegia
  • Spasticity
  • Arm
  • Hand

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.