Implementation of Comprehensive Stroke Rehabilitation Therapy for Enhanced Quality of Life

NCT02225990 | Completed

• 1 other identifier: IRB201400568
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this research study is to implement into clinical practice, the comprehensive QualPro protocol for stroke survivors, which includes gait coordination, balance, mobility, and fitness training. Feasibility will be tested in the clinical environment by providing the intervention, measuring patient outcomes, and identifying the obstacles to insurance payment for the QualPro intervention. By productively addressing issues of implementation, the hypotheses of this study include proven feasibility in the clinical environment and clinically significant gains for stroke patients in the areas of strength, balance, gait coordination, endurance, physical function, and increased life role participation.

Conditions

Stroke

Keywords

stroke; stroke rehabilitation; stroke therapy

Outcome Measures

Primary Outcomes (1)

• Patient response to QualPro intervention in the clinical environment

  Implementation of the comprehensive QualPro protocol into clinical practice will be done in order to determine patient outcomes during interventions of gait coordination, balance, mobility, and fitness training.

  24 months

Secondary Outcomes (1)

• Cost savings of implementation of the QualPro Protocol

  24 Months

Study Arms (4)

Standard of Care, Sub-Acute

ACTIVE COMPARATOR

This group will receive standard of care stroke rehabilitation therapy.

Other: Standard of Care, Sub-Acute

Standard of Care, Chronic

ACTIVE COMPARATOR

This group will receive standard of care stroke rehabilitation therapy.

Other: Standard of Care, Chronic

Experimental Group, Sub-Acute

EXPERIMENTAL

This group consists of sub-acute stroke patients who are between three weeks and six months post-stroke and will receive the QualPro protocol. If the participant is an inpatient at Shands Rehabilitation Hospital at the beginning of the study, his/her first three weeks of research therapy sessions will take place at the Shands Rehabilitation Hospital. After being discharged, the remainder of the study sessions will take place at either UF Health Rehab Center- Magnolia Parke or in the North Tower (6th floor) physical therapy department of Shands Hospital.

Other: Experimental Group, Sub-Acute

Experimental Group, Chronic

EXPERIMENTAL

This group consists of chronic stroke patients who are greater than six months post-stroke and will receive the QualPro protocol. The study sessions will take place at either UF Health Rehab Center-Magnolia Parke or in the North Tower (6th floor) physical therapy department of Shands Hospital.

Other: Experimental Group, Chronic

Interventions

Experimental Group, Sub-Acute OTHER

For the sub-acute experimental group, the intervention schedule will be as follows: six months of individual therapy five times weekly (1 - 2.5 hours/session); 6 months of 'refresher' individual therapy twice monthly (1 - 2.5 hours/session) + group therapy up to three times weekly (1 hour/session); and 1 year of group therapy, up to three times weekly (1 hour/session) + 1 'refresher' individual therapy session every 3 months for a total study duration of 2 years.

Experimental Group, Sub-Acute

Experimental Group, Chronic OTHER

For the chronic experimental group, the intervention schedule will be as follows: six months of individual therapy five times weekly (1 - 2.5 hours/session); 6 months of 'refresher' individual therapy twice monthly (1 - 2.5 hours/session) + group therapy up to three times weekly (1 hour/session); and 1 year of group therapy, up to three times weekly (1 hour/session) + 1 'refresher' individual therapy session every 3 months for a total study duration of 2 years.

Experimental Group, Chronic

Standard of Care, Sub-Acute OTHER

This group will receive standard of care stroke rehabilitation therapy.

Standard of Care, Sub-Acute

Standard of Care, Chronic OTHER

This group will receive standard of care stroke rehabilitation therapy.

Standard of Care, Chronic

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cognition sufficiently intact to give valid informed consent to participate.
• Sufficient endurance to participate in rehabilitation sessions.
• Ability to follow 2 stage commands.
• Medically stable
• Age \> 21 years
• Impaired ambulation as follows: inability to flex the knee and ankle in the sagittal plane, in a normal manner so the foot clears the floor; inability to control normal knee angle during single limb weight bearing during stance phase.
• Trace contraction of hip, knee, and ankle flexors and extensors.
• Passive range of motion (ROM) at hip, knee, ankle greater than or equal to normal gait kinematics.
• Reported comfort of surface FES at a stimulus level producing a visible or palpable muscle contraction of ankle dorsiflexors.
• Greater than 3 weeks post-stroke.
• Living in the community and able to travel to training and assessment sites.
• Approval of participation by primary care physician

You may not qualify if:

• Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy.
• Active psychiatric diagnosis or psychological condition, or active drug/alcohol abuse.
• Lower motor neuron damage or radiculopathy.
• More than one stroke.
• Cerebellar dysfunction.
• Fugl-Meyer lower limb motor sub-score greater than 32.
• Severe obesity (body mass index \> 35)
• For the chronic group: current participation in physical therapy or cardiopulmonary rehabilitation.
• Significant visual impairment affecting capability to gauge movement accuracy.
• Current enrollment in any clinical trial
• Planning to relocate out of the greater Gainesville, FL area during the study period
• Unable to communicate sufficiently with study personnel
• Clinical judgement regarding safety or non-compliance
• Refusal to be recorded by video for gait assessment

Sponsors & Collaborators

• University of Florida: lead

Study Sites (3)

UF Health Rehab Center- Magnolia Parke

Gainesville, Florida, 32606, United States

Location

UF Health Shands Rehab Hospital

Gainesville, Florida, 32606, United States

Location

Brain Rehabilitation Research Center

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Janis J. Daly, PhD, MS

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 26, 2014
• Study Start: July 1, 2015
• Primary Completion: December 27, 2018
• Study Completion: December 27, 2018
• Last Updated: September 4, 2019

Record last verified: 2019-08

Locations

US (3)