NCT02925039

Brief Summary

The sit-to-stand (STS) movement is a key functional movement critical to independent living. This movement is physically demanding to conduct, especially in older adults, and in the presence of physical impairments associated with a range of conditions, such as stroke, osteoarthritis, Parkinson disease and hip arthroplasty. A limited capacity to perform this movement increases the risk of falls, dependency and increased support for personal care and rehabilitation. Restoring independence in this movement is, therefore, considered a priority for physical rehabilitation. Sit-to-stand capacity can be regained through participating in rehabilitation exercises. Providing feedback on performance of this movement could enhance the training. Thus, it is an essential aspect of physical therapy. Healthcare providers are required to meet the needs of an increasingly frail population as well as meeting national, evidence-based, guidelines for improving outcomes in conditions such as stroke which includes an increase in the practice repetition of functional movements. Reliance on rehabilitation staff to provide practice, however, places a limit on practice volume, potentially restricting outcomes. Using technology to enhance safe, repetitive practice of this movement with minimal supervision from skilled professionals would be beneficial to patients and rehabilitation services. The primary aim of this study is to test the acceptability and feasibility of a STS training system that enhances movement feedback to patients undergoing rehabilitation. A secondary aim is to gather data on the effectiveness of the system compared to conventional rehabilitation. This information will inform a statistically powered phase 2 trial.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

April 18, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

12 months

First QC Date

October 4, 2016

Last Update Submit

May 10, 2017

Conditions

Keywords

RehabilitationGeriatric

Outcome Measures

Primary Outcomes (1)

  • sit to stand ability

    Five times sit to stand test

    6 weeks

Secondary Outcomes (1)

  • Acceptability

    6 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Sit to stand training augmented with technology delivered movement feedback

Other: Rehab with computer feedback

Control

ACTIVE COMPARATOR

Sit to stand training as per normal practice

Other: Treatment as usual

Interventions

Sit to stand training with addition of computerised feedback (speed, symmetry and trunk tilt)

Experimental

Treatment as usual

Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients admitted to the geriatric rehabilitation ward at Gartnavel General (Greater Glasgow and Clyde Health Board).
  • Patients with physical impairments that affect their ability to stand up from sitting (sit to stand).
  • Patients that are medically stable.
  • Patients able to give informed consent.
  • Patients able to complete a STS movement with/without the help of a mobility aid or assistance of one other person.
  • Patients able to follow a three-word instruction in English.

You may not qualify if:

  • Patients unable to read feedback on a computer screen with or without the use of visual aids.
  • Patients known to be epileptic/photosensitive or experience blackouts when exposed to certain light patterns or flashing images.
  • Patients with coexisting physical impairments which prevent the practice of sit-to-stand e.g. bilateral amputee or an acute exacerbation of rheumatoid arthritis.
  • Patients not expected to survive during the period of the study
  • Patients with active dermatological problems that may preclude the use of double sided sticky tape.
  • Patients with active medical conditions that may limit prescribed mobility exercise e.g. unstable angina.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gartnavel General Hospital

Glasgow, Scotland, G44 3RL, United Kingdom

RECRUITING

MeSH Terms

Interventions

RehabilitationTherapeutics

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Andrew Kerr

    University of Strathclyde

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Kerr, PhD

CONTACT

Sui Ho Fan, M.Eng

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Pilot Randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 5, 2016

Study Start

April 18, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2019

Last Updated

May 11, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations