Progressive Abduction Loading Therapy

NCT04118998 | Active Not Recruiting

• 2 other identifiers: STU00209671R01HD096071
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 3

Brief Summary

This study attempts to minimize the development of a common movement impairment following stroke known as "flexion synergy" that makes it extremely difficult to reach outward with the arm. Participants with acute/subacute stroke will receive one of two study interventions in addition to prescribed therapies in both inpatient rehabilitation and day-rehab. Participants will be followed for 1 year.

Conditions

Stroke, Acute

Keywords

Rehabilitation; Arm; Flexion Synergy; Longitudinal; Targetted; Quantitative

Outcome Measures

Primary Outcomes (1)

• Change in Reaching Function

  Quantitative evaluation of reaching by calculating distance from reaching kinematics data during ballistic outward reaches against gravity.

  Change in Reaching function will be modeled from baseline, weekly (until discharge from rehabilitation, on average 4 to 10 weeks), and monthly evaluations (every-other month until 12 months post-stroke).

Secondary Outcomes (4)

• Change in Loss of Independent Joint Control

  Change in Loss of Independent Joint Control will be modeled from baseline, weekly (until discharge from rehabilitation, on average 4 to 10 weeks), and monthly evaluations (every-other month until 12 months post-stroke).

• Change in Fugl-Meyer Motor Assessment

  Change in Fugl-Meyer Motor Assessment will be modeled from baseline, weekly (until discharge from rehabilitation, on average 4 to 10 weeks), and monthly evaluations (every-other month until 12 months post-stroke).

• Change in Action Research Arm Test

  Change in Action Research Arm Test will be modeled from baseline, weekly (until discharge from rehabilitation, on average 4 to 10 weeks), and monthly evaluations (every-other month until 12 months post-stroke).

• Change in Stroke Impact Scale

  Change in Stroke Impact Scale will be modeled from baseline, weekly (until discharge from rehabilitation, on average 4 to 10 weeks), and monthly evaluations (every-other month until 12 months post-stroke).

Study Arms (2)

Abduction Loading

EXPERIMENTAL

The intervention for the experimental group entails practicing reaching with abduction loading.

Behavioral: Abduction Loading

Supported Reaching

ACTIVE COMPARATOR

The intervention for the active comparator entails practicing reaching while supported.

Behavioral: Supported Reaching

Interventions

Abduction Loading BEHAVIORAL

The intervention for the experimental group entails practicing reaching with abduction loading.

Also known as: Progressive Abduction Loading Therapy

Abduction Loading

Supported Reaching BEHAVIORAL

The intervention for the active comparator entails practicing reaching while supported.

Supported Reaching

Eligibility Criteria

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

You may qualify if:

• Hemiparesis confined to one side, (CMSA Stage 2 or 3 out of 7)
• Stroke impacting parenchyma of the middle cerebral artery distribution
• Within 90 days post-stroke
• to 85 years old
• No or Mild-to-moderate Aphasia (NIHSS #9 Best Language. = 0 or 1- Describe picture; No or Mild-to-moderate Aphasia)
• No or Mild extinction and inattention (NIHSS 11 Extinction and Inattention. = 0 or 1- No abnormality or Inattention to one modality.)
• Ability to perform a 3-step motor command with the unaffected arm
• Capacity to provide informed consent

You may not qualify if:

• Premorbid and persistent disability or motor impairment of the upper extremities
• Brainstem and/or cerebellar lesion
• Comorbidity medically contraindicating motor assessments
• Any other chronic neurological condition
• Pain or hypersensitivity limiting motor assessments
• Limb edema limiting study motor assessments

Sponsors & Collaborators

• Northwestern University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Shirley Ryan AbilityLab: collaborator
• Marianjoy Rehabilitation Hospital & Clinics: collaborator

Study Sites (3)

Department of Physical Therapy and Human Movement Sciences

Chicago, Illinois, 60611, United States

Location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Northwestern Medicine Marianjoy Rehabilitation Hospital

Wheaton, Illinois, 60187, United States

Location

Related Publications (4)

• Yamada K. The glossophyaryngeal nerve response to taste and thermal stimuli in the rat, rabbit and cat. Kumamoto Med J. 1965 Jun 30;18(2):106-8. No abstract available.

  PMID: 5825888 BACKGROUND

• Martig J, Riser WH, Germann F. Deforming ankylosis of the coffin joint in calves. Vet Rec. 1972 Sep 23;91(13):307-10. doi: 10.1136/vr.91.13.307. No abstract available.

  PMID: 5086410 BACKGROUND

• Chou MY, Malison MD. Outbreak of acute hemorrhagic conjunctivitis due to coxsackie A24 variant--Taiwan. Am J Epidemiol. 1988 Apr;127(4):795-800. doi: 10.1093/oxfordjournals.aje.a114861.

  PMID: 2833097 BACKGROUND

• Roth HR, Carmona C, Clark G, Gyarmaty JE, Dewald JPA, Giblin E, Harvey RL, Jaskiewicz J, Kim KA, Lancki N, Luhrsen A, Mandana A, Manikonda D, Morris A, Sheth S, Stoykov ME, Young AC, Zielke D, Ellis MD. PRALINE: study protocol for a phase IIb inpatient stroke rehabilitation randomized controlled trial investigating longitudinal outcomes after progressive abduction loading therapy. Trials. 2025 Jul 20;26(1):250. doi: 10.1186/s13063-025-08969-6.

  PMID: 40685355 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael D Ellis, PT, DPT

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The two arms or study interventions are indistinguishable by patients and untrained observers. The Care Providers (Study Intervention Therapists) can not be masked due to their knowledge in the delivery of the physical intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: October 8, 2019
• Study Start: August 27, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data sharing in the above repositories will be phased in time with acceptance for publication of the primary outcome paper near the end of the fifth year and then with each subsequent publication.
• Access Criteria: Data sharing will occur through the primary repositories of NICHD DASH (https://dash.nichd.nih.gov/), Northwestern University DigitalHub (https://digitalhub.northwestern.edu/), and Open Science Framework (https://osf.io/). Data will be exported from the internal RedCap study data base in spreadsheet format and will be deidentified and coded. Data will be available through speaking engagements and publications, presentations at scientific symposia and seminars.

Locations

US (3)