Post-Stroke Optimization of Walking Using Explosive Resistance

NCT03826771 | Completed Phase 2 Results

• 2 other identifiers: 00077223R01HD095137
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will study the effects of a 12 week strength training program on individuals who have had a stroke and are depressed to see if this type of exercise training helps treat depression and improves walking function. Our goal is to use the information collected in this study to help design treatments for people who have had a stroke that will help with many of the common consequences of stroke, including depression, muscle weakness and slow walking. Progress toward overcoming some of these issues would be incredibly valuable to any person who has had a stroke and their families.

Conditions

Stroke; Depression

Keywords

stroke; rehabilitation; depression; exercise

Outcome Measures

Primary Outcomes (1)

• Change in Mean Score of Depression as Assessed by the Hamilton Rating Scale for Depression

  The HAM-D is a clinician-rated scale with scores based on clinical interview and family report. It addresses both somatic and psychological symptoms of depression. Items are rated on either a 5-point scale (0 to 4) or 3-point scale (0 to 2), where higher scores represent increasing severity of depression. The scores of the 17 items are summed to obtain a total score (minimum score: 0, maximum score: 52).

  Visit 1 through visit 24 (up to 12 weeks)

Secondary Outcomes (1)

• Change in Self Selected Walking Speed

  Visit 1 through visit 24 (up to 12 weeks)

Study Arms (2)

POWER training

EXPERIMENTAL

high velocity strength training

Behavioral: Power training

Stretching

ACTIVE COMPARATOR

Upper and lower body range of motion exercises

Behavioral: Stretching

Interventions

Power training BEHAVIORAL

high-intensity lower extremity resistance training

POWER training

Stretching BEHAVIORAL

upper and lower body range of motion exercises

Stretching

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 50-70
• stroke within the past 6 to 60 months
• residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34)
• ability to walk without assistance and without an AFO during testing and training at speeds ranging from 0.2-0.8 m/s
• no antidepressant medications or no change in doses of psychotropic medication for at least 4 weeks prior to the study (6 weeks if newly initiated medication)
• HRSD question #9 regarding suicide \<2; and 7) provision of informed consent.

You may not qualify if:

• Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking
• history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's
• History of COPD or oxygen dependence
• Preexisting neurological disorders, dementia or previous stroke
• History of major head trauma
• Legal blindness or severe visual impairment
• history of psychosis or other Axis I disorder that is primary
• Life expectancy \<1 yr.
• Severe arthritis or other problems that limit passive ROM
• History of DVT or pulmonary embolism within 6 months
• Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
• Severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest
• attempt of suicide in the last 2 years or at suicidal risk assessed by SCID interview
• History of seizures or currently prescribed anti-seizure medications
• Current enrollment in a clinical trial to enhance motor recovery

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stroke; Depression; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Chris Gregory
• Organization: Medical University of South Carolina

gregoryc@musc.edu

843-792-1078

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 1, 2019
• Study Start: February 6, 2019
• Primary Completion: March 15, 2024
• Study Completion: May 12, 2024
• Last Updated: April 24, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-04

Locations

US (1)