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Sit-to-Stand Progression Using Movi Chair vs Traditional Practices

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ClinicalTrials.gov Identifier: NCT03103464
Recruitment Status : Not yet recruiting
First Posted : April 6, 2017
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Lavon Beard, University of Alabama at Birmingham

Brief Summary:
Prior to discharging admitted patients, current UAB Hospital policy recommends physical therapy intervention for patients with impaired functional mobility. However, UAB Hospital currently does not have a standardized physical therapy protocol to rehabilitate admitted patients with impaired functional mobility who require moderate assist (defined as physical therapist expending 25-50% effort to assist the patient in standing). In order to reduce the effect of impaired mobility, numerous interventions have been employed at UAB. As a result, there is great variability of treatment procedures performed by various physical therapists to help moderate assist patients return to their level of functioning prior to hospital admission. The purpose of the study is three-fold: 1) to evaluate whether a proposed physical therapy protocol using a commercially available medical device, the Movi chair, contributes to improved mobility for moderate assist patients, 2) to investigate how patient rate of rehabilitation to prior level of functioning is similar/different with the proposed physical therapy protocol using Movi vs the current non-standardized practice for moderate assist patients, and 3) to compare patient confidence in physical therapy with Movi vs the current non-standardized practice using survey for moderate assist patients. In addition, we will track participant's disposition i.e. continued motor and functional change following discharge from the hospital through review of physical therapy records.

Condition or disease Intervention/treatment Phase
Physical Activity Other: Standard-of-Care Therapy + Sit-to-Stand Therapy Other: Standard-of-Care Therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: Patient's primary physical therapist will not be aware whether the patient is in the intervention or control group.
Primary Purpose: Treatment
Official Title: Sit-to-Stand Progression Using Movi Chair vs Traditional Practices
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intervention Group
Patients to receive standard-of-care physical therapy + sit-to-stand therapy using the Movi chair 3x/wk.
Other: Standard-of-Care Therapy + Sit-to-Stand Therapy
Standard-of-care physical therapy 3x/wk for approximately 30 minutes each time + sit-to-stand training using the Movi chair 3x/wk for approximately 10 minutes each time.
Active Comparator: Control Group
Patients to receive standard-of-care physical therapy 3x/wk.
Other: Standard-of-Care Therapy
Standard-of-care physical therapy 3x/wk for approximately 30 minutes each time.



Primary Outcome Measures :
  1. Rate of progression from moderate to minimal assist [ Time Frame: Through study completion, an average of 2 weeks ]
    Patient rate of progression from moderate (<50% assistance from physical therapist) to minimal (<25% assistance from physical therapist) assist during hospital admission


Secondary Outcome Measures :
  1. Hierarchical Assessment of Balance and Mobility Score [ Time Frame: Through study completion, an average of 2 weeks ]
    Score grading the patient on balance, mobility, and transfers on a 0-28 scale

  2. Five-time sit-to-stand time [ Time Frame: Through study completion, an average of 2 weeks ]
    Time for patient to complete sit-to-stand 5x from standard chair



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients receiving physical therapy at UAB hospital that require moderate assistance or greater with sit-to-stand transfers during initial evaluation
  • Patients with baseline function of supervision as obtained in the initial physical therapy (PT) evaluation
  • Patients who have an inpatient hospital stay of at least 4 days

Exclusion Criteria:

  • Patients with diagnoses that are progressive in nature
  • Patients in intensive care units due to critical medical condition and confounding factors
  • Patients with cognitive impairment as noted in the medical record
  • Patients with weight bearing precautions other than free weight bearing (FWB) or weight bearing as tolerated (WBAT)
  • Children (under the age of 18), prisoners and pregnant women
  • Patients who are not able to speak English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103464


Contacts
Contact: Amy Hayes, DPT 205-934-4287 alhayes@uabmc.edu

Locations
United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35205
Contact: Amy Hayes, DPT    205-934-4287    alhayes@uabmc.edu   
Principal Investigator: Lavon Beard, DPT, MBA         
Sub-Investigator: Amy Hayes, DPT         
Sub-Investigator: Kwasi Asare, DPT, MBA         
Sub-Investigator: Meredith Erdman, DPT         
Sub-Investigator: Tristan Gass, DPT         
Sub-Investigator: Elise Aurilio, DPT         
Sub-Investigator: Melanie Linford, DPT         
Sub-Investigator: Helen Smith, DPT         
Sub-Investigator: Tracy Stevens, DPT         
Sub-Investigator: Nicole Pierson, DPT         
Sub-Investigator: Valeria Makeeva, MD 6/2017         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Lavon Beard, DPT, MBA Manager Physical Therapy, Doctor of Physical Therapy

Responsible Party: Lavon Beard, Principle Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03103464     History of Changes
Other Study ID Numbers: X161207007
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No