Self Directed Stations for the Stroke Patient

NCT02446197 | Completed

• 1 other identifier: 014-203
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Early initiation of therapy post stroke has been associated with improved long-term outcomes, and functional activity dose during the first week of inpatient rehabilitation predicts both gait velocity at discharge and length of time to independent walking. The primary study objective is to pilot the feasibility of integrating a patient-directed activity program into inpatient rehabilitation following stroke. The second study objective is to identify if participation in the patient-directed activity program improves functional ability and health related quality of life.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Rehabilitation Participation Scale

  Daily measurements will be recorded during inpatient hospitalization to capture changes in participation between admission and discharge and to calculate sums/averages of participation.

  Daily during inpatient rehab hospitalization, time frame maximum is up to 3 months

Secondary Outcomes (7)

• Stroke Rehabilitation Assessment of Movement Measure (STREAM)

  Wtihin one week of rehab inpatient admission, within one week of rehab inpatient discharge, at post discharge follow up (3-6 months after inpatient rehab discharge)

• WOLF Motor Function Test

  Wtihin one week of rehab inpatient admission, within one week of rehab inpatient discharge, at post discharge follow up (3-6 months after inpatient rehab discharge)

• Actigraph

  Wtihin one week of rehab inpatient admission, within one week of rehab inpatient discharge

• Functional Independence Measure

  Wtihin one week of rehab inpatient admission, within one week of rehab inpatient discharge, at post discharge follow up (3-6 months after inpatient rehab discharge)

• Stroke Impact Scale

  Within one week of rehab inpatient discharge, at post discharge follow up (3-6 months after inpatient rehab discharge)

Study Arms (2)

Patient Directed Exercise Group

EXPERIMENTAL

Participants will complete a combination of PT and OT activities that will be individually prescribed based on an evaluation by the therapy team completed pre-intervention. The activities will be added to the comprehensive inpatient rehabilitation program.

Other: Patient Directed Exercise Group

Standard of care

NO INTERVENTION

Standard of care comprehensive inpatient rehabilitation program.

Interventions

Patient Directed Exercise Group OTHER

Combination of PT and OT activities that will be individually prescribed based on an evaluation by the therapy team completed pre-intervention. The activities will be added to the comprehensive inpatient rehabilitation program.

Patient Directed Exercise Group

Eligibility Criteria

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

You may qualify if:

• years of age and older
• Safe to be left unsupervised as deemed by therapist or has caregiver present
• Diagnosed with stroke in past six months
• Medically stable as deemed by therapy team
• \>3 on FIM comprehension
• Primary diagnosis of stroke (all types)

You may not qualify if:

• Pre-morbid developmental disability
• Significant pre-morbid psychological diagnosis or concurrent TBI
• Other cognitive impairment that would prevent participation as determined by the clinician

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Research Institute

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Molly Trammell, PT

  Physical Therapist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: May 18, 2015
• Study Start: October 1, 2014
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 7, 2019

Record last verified: 2019-06

Locations

US (1)