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Physical ActivityNCT03103464

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

A study testing Standard-of-Care Therapy + Sit-to-Stand Therapy and Standard-of-Care Therapy in people with Physical Activity, run by University of Alabama at Birmingham at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Physical Activity
What is being tested?
Standard-of-Care Therapy + Sit-to-Stand Therapy and Standard-of-Care Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 May 2018to Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205

Other trials in United States

About this study

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.

Read the detailed description

Most activities of daily living require unassisted ability to stand from a sitting position. Therefore, physical therapy exercises aimed at improving this essential action are critically important for patients with impaired functional mobility. Although sit-to-stand tests are a well-known tool used to assess physical function, they have only recently has been proposed for systematic strength training.

Those patients who would most benefit from sit-to-stand training require moderate assist or greater. However, these patients have significant difficulty initiating sit-to-stand exercises from a horizontal chair surface and have been largely excluded from prior studies examining sit-to-stand for strength training. These patients have been excluded not only because they cannot safely stand on their own, but also because manually lifting these patients poses a significant lifting-injury risk to physical therapists.

Movi is a commercially available hybrid mechanical lift and chair who's key feature is a built in battery powered motor (rated for 600 lbs) that pivots on its axis to raise and lower a patient up to 20 degrees. We believe that this feature represents an opportunity for introducing sit-to-stand strength training to previously excluded moderate assist patients. Progressively lowering the chair's angle of inclination over consecutive physical therapy sessions will allow the patient to practice sit-to-stand at a reduced effort until the to horizontal angle is reached.

As sit-to-stand strength training is a concept only proposed in 2011, no previous studies exist concerning a sit-to-stand physical therapy protocol using a chair progressively lowering the seat's angle of inclination. Currently, therapists use their clinical judgment when approaching patients with difficulty standing by utilizing exercise, skill repetition, in addition to other strengthening strategies and equipment to reach goals. Timed sit-to-stand has already been used at UAB in order to test a patient's progress in physical therapy but not as a therapy protocol in itself, partly because equipment allowing progressive lowering of the seat's angle of inclination has not been available until now. This study was conceived due to the great variability of physical therapy in the Hospital setting and the critical need for standardization and evaluating a protocol that has potential to positively impact patient speed and ease of recovery to prior level of functioning.

The therapy protocol utilizing the Movi chair will include the following:

  1. Mobilize patient to Movi chair (via lift or manual transfer)
  2. Document lowest height in 5 degree increments (in degrees from inclinometer attached to Movi chair) where patient is able to complete a sit-to-stand transfer with minimal assistance (defined as requiring < 25% effort from the physical therapist) allowing patient to use his or her arms on thighs or armrests if needed.
  3. The patient will perform 5 sit-to-stand transfers from this level, rest until recovery, and do additional sets to increase muscle strength only if able.
  4. During subsequent visits, patient will begin at prior set level. If able to perform a sit-to-stand transfer with less than minimal assistance, the elevation of the chair will be lowered by 5 degree increments until able to complete a sit-to-stand transfer with minimal assistance or greater and the patient will perform sit-to-stand transfer repetitions from the new height.
  5. This protocol will continue until the patient is able to perform a sit-to-stand transfer from a standard height chair with supervision assistance or until the patient is discharged to the next level of care
  6. Once able to complete a sit-to-stand transfer from a standard height, a five-time-sit-to-stand (FTSST) will be performed 3 times per week.

Treatment of the control group will utilize standard recliners and traditional therapy methods (transfer training, therapeutic exercise). Once an investigator consents the patient for the study, if the patient has been randomized to either control group or intervention group, a non-investigator physical therapist will perform his or her usual physical therapy exercises to minimize bias from study investigators completing therapy. Investigators will test FTSST time for patients in the control group 3 times per week. Only investigators will treat the intervention group using the above outlined protocol 3 times per week. Once intervention group patients are able to complete a sit-to-stand transfer from a standard height, a FTSST will be performed 3 times per week by a study investigator. Investigators will also record the Hierarchical Assessment of Balance and Mobility (HABAM) score for intervention group patients when they test FTSST time as an added measure of mobility. The HABAM is an interval level mobility instrument that is already in use as a valid and reliable mobility instrument in the older acute medical population. This score does not require any additional exercises with the patient beyond the FTSST. Investigators will ask the non-investigator physical therapists caring for the control group patients to estimate control group patients' HABAM, which can be easily estimated after working with the patient during routine standard of care therapy.

Being tested
Standard-of-Care Therapy + Sit-to-Stand Therapy, Standard-of-Care Therapy
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard-of-Care Therapy + Sit-to-Stand TherapyOther

    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.

  • Standard-of-Care TherapyOther

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

Study groups in NCT03103464
Study groupRoleWhat they receive
Intervention GroupExperimentalPatients to receive standard-of-care physical therapy + sit-to-stand therapy using the Movi chair 3x/wk.
Receives: Other: Standard-of-Care Therapy + Sit-to-Stand Therapy
Control GroupActive comparatorPatients to receive standard-of-care physical therapy 3x/wk.
Receives: Other: Standard-of-Care Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Through study completion, an average of 2 weeks

Secondary outcomes (2)
  1. Hierarchical Assessment of Balance and Mobility Score

    Score grading the patient on balance, mobility, and transfers on a 0-28 scale

    Measured: Through study completion, an average of 2 weeks

  2. Five-time sit-to-stand time

    Time for patient to complete sit-to-stand 5x from standard chair

    Measured: Through study completion, an average of 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2017
  2. Study start1 May 2018 (estimated)
  3. Primary completionJul 2018 (estimated)
  4. Study completionJul 2018 (estimated)

Why it stopped: No one consented for this study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03103464
Sponsor's protocol ID
X161207007
Status last verified
Aug 2018
First submitted
28 Mar 2017
Last updated
10 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Standard-of-Care Therapy + Sit-to-Stand Therapy and Standard-of-Care Therapy in people with Physical Activity, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of progression from moderate to minimal assist (time frame: Through study completion, an average of 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.

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