NCT03103464

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

March 28, 2017

Last Update Submit

August 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of progression from moderate to minimal assist

    Patient rate of progression from moderate (\<50% assistance from physical therapist) to minimal (\<25% assistance from physical therapist) assist during hospital admission

    Through study completion, an average of 2 weeks

Secondary Outcomes (2)

  • Hierarchical Assessment of Balance and Mobility Score

    Through study completion, an average of 2 weeks

  • Five-time sit-to-stand time

    Through study completion, an average of 2 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

Patients to receive standard-of-care physical therapy 3x/wk.

Other: Standard-of-Care Therapy

Interventions

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.

Intervention Group

Standard-of-care physical therapy 3x/wk for approximately 30 minutes each time.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Lavon Beard, DPT, MBA

    Manager Physical Therapy, Doctor of Physical Therapy

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Patient's primary physical therapist will not be aware whether the patient is in the intervention or control group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 6, 2017

Study Start

May 1, 2018

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

August 10, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations