Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model

NCT03634397 | Completed Results DMC

• 2 other identifiers: STUDY00008385R01HD059783-06A1
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

This study will test the hypothesis that the combination of low-moderate to severe motor deficits in the paretic arm and persistent motor deficits in the less-impaired arm limits functional independence in chronic stroke survivors. We, therefore, predict that intense remediation, focused on improving the speed, coordination, and accuracy of the less-impaired arm should improve functional independence.

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• Change in Jebsen-Taylor Hand Function Test (JTHFT) Times From Baseline 2 to Post Test 1

  Measure of unimanual arm performance in a wide range of hand functions required for activities of daily living. The test includes 7 timed (seconds) activities (possible 0-120 seconds each); the analysis excludes the writing component, therefore it includes 6 of the 7 original JTHFT components. Faster performance yields lower scores (time). There were 2 baseline tests (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score as the starting value and do not include the first baseline scores.

  Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

• Change in Abilhand Scores From Baseline 2 (Prior to Treatment) to Post Test 1

  Participant reported outcome of difficulty of upper extremity based activities. Scores are transformed to logit scores. The items ranged on the interval scale from -2.18 to 1.72 log-odds units, called 'logits', with higher logit values indicating more difficult activities. Deltas of logits from baseline 2 to post test 1 are reported. There were two baseline assessments (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score (when participants were randomized) as the starting value and do not include the first baseline scores. Results do not include covariates.

  Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

• Change of Score on Barthel Index From Baseline 2 (Prior to Training) to Post Test 1

  Measure of functional independence in self care activities scored from 0-100 with higher scores indicating more functional independence. There were two baseline assessments (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score (when participants were randomized) as the starting value and do not include the first baseline scores.

  Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

• Change in Upper-Extremity Fugl-Meyer Assessment (FM) Score From Baseline 2 (Prior to Training) to Post Test 1

  Upper-Extremity Measure of paretic arm impairment out of 66 possible points with higher scores indicating more movement, and 0 indicating no functional movement in the arm. There were two baseline assessments (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score (when participants were randomized) as the starting value and do not include the first baseline scores.

  Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

Secondary Outcomes (3)

• Change From Baseline 2 (Prior to Training) to Post Test 1on Functional Independence Measure (FIM) -Self Care Components

  Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

• Change From Baseline 2 (Prior to Training) to Post Test 1 on Contralesional Work Space Area (Kinematics)

  Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

• Change in Kinematics- Positional Variability at Maximum Velocity From Baseline 2 (Prior to Training) to Post Test 1

  Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

Study Arms (2)

Less-Impaired Arm Training

EXPERIMENTAL

Intervention condition includes therapy of the less-impaired (ipsilesional) arm.

Behavioral: Less-Impaired Arm Training

Contralesional Arm Comparison

SHAM COMPARATOR

Comparison control condition includes therapy of the paretic (contralesional) arm.

Behavioral: Contralesional Arm Comparison

Interventions

Less-Impaired Arm Training BEHAVIORAL

Participants receive virtual reality and manipulation training in their less impaired arm.

Less-Impaired Arm Training

Contralesional Arm Comparison BEHAVIORAL

Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.

Also known as: sham condition

Contralesional Arm Comparison

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• neuroradiological confirmation of unilateral brain damage with residual contralesional upper-extremity weakness
• deficits in ipsilesional arm performance assessed by the JTHFT
• + months post stroke
• Demonstrates cognitive abilities

You may not qualify if:

• a history of:
• neurological disease other than stroke (e.g., head trauma)
• a major psychiatric diagnosis (e.g., schizophrenia, major affective disorder),
• hospital admission for substance abuse
• peripheral disorders affecting sensation or movement of the upper extremities, including pain or arthritis
• currently taking prescription drugs with known sedative properties that are interfering with sensory-motor function
• significant joint pain that is activity limiting
• bilateral stroke

Sponsors & Collaborators

• Robert L. Sainburg: lead
• University of Southern California: collaborator
• Penn State University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

University of Southern California

Los Angeles, California, 90089, United States

Location

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (2)

• Maenza C, Winstein CJ, Murphy TE, Kitchen NM, Tanaka J, Yuk J, Varghese R, Sainburg RL. Targeted Remediation of the Ipsilesional Arm in Chronic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2026 Feb 2:e255496. doi: 10.1001/jamaneurol.2025.5496. Online ahead of print.

  PMID: 41627841 DERIVED

• Maenza C, Sainburg RL, Varghese R, Dexheimer B, Demers M, Bishop L, Jayasinghe SAL, Wagstaff DA, Winstein C; IPSI Investigative Team. Ipsilesional arm training in severe stroke to improve functional independence (IPSI): phase II protocol. BMC Neurol. 2022 Apr 12;22(1):141. doi: 10.1186/s12883-022-02643-z.

  PMID: 35413856 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Study was ongoing during the start of the Covid epidemic and the laboratory was shut down for an extended period of time resulted in lower than expected number of participants.

Results Point of Contact

• Title: Dr Candice Maenza
• Organization: Penn State College of Medicine

cmaenza@pennstatehealth.psu.edu

7175310003

Study Officials

• Robert L Sainburg, Phd, OTR

  Penn State University

  PRINCIPAL INVESTIGATOR

• Carolee J Winstein, PhD,PT

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will assess all participants and be unaware of the participants' group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Kinesiology and Neurology

Model Details: Participants are randomly assigned to one of two groups. One group (treatment group) receives remediation therapy of the less impaired arm while the control group receives paretic arm therapy.

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: August 16, 2018
• Study Start: February 2, 2019
• Primary Completion: February 22, 2024
• Study Completion: August 5, 2024
• Last Updated: September 12, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within one year of study completion, available for a minimum of one year.
• Access Criteria: The web address is open to the public.

Locations

US (2)