NCT02620462

Brief Summary

Knee osteoarthritis (KOA) is one of the leading causes of lower limb disability among the elderly and can cause loss of knee joint proprioception that contributes towards deterioration of postural balance. Maintaining a good postural stability is essential while performing everyday functional activities and to avoid falls. Exercise training has been reported to reduce pain as well as improve performance of functional tasks in patients with KOA however compliance to exercise can be challenging due to pain, lack of motivation and traditional nature of exercise that can easily overtax patients. Furthermore, there are not exercise programs that are specifically designed for patients with KOA in order to address lost knee joint proprioception. Recent studies have also demonstrated that visual feedback during exercise can enhance the benefits of exercise training. Therefore, the aim of the proposed study is to implement an interactive sensor-based exercise training to improve postural balance, gait and activities of daily living in patients with KOA.

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
24

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable knee-osteoarthritis

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

2.1 years

First QC Date

June 8, 2015

Last Update Submit

May 16, 2016

Conditions

Keywords

Postural BalancePainGaitPhysical Activity Level

Outcome Measures

Primary Outcomes (1)

  • Body Sway as an indicator of postural control

    Body sway including ankle sway, hip sway, and center of mass sway

    6 weeks

Secondary Outcomes (3)

  • Knee injury and Osteoarthritis Outcome Score

    6 weeks

  • Gait

    6 weeks

  • Pain

    6 weeks

Study Arms (2)

Wearable sensor-based exercise training

EXPERIMENTAL

The intervention group in addition to standard of care, will receive 6 weeks of sensor-based balance training that provides real-time visual feedback of lower extremities during exercise. The visual feedback is provided on computer screen.

Device: Wearable sensor-based exercise training

Control Group

NO INTERVENTION

The control group only receives standard of care.

Interventions

The device provides real-time visual feedback of joint movement during balance exercise

Wearable sensor-based exercise training

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 and above
  • ability to walk 50 m independently (with or without aid)
  • ability to stand for 5 minutes .

You may not qualify if:

  • disorder other than osteoarthritis that may severely affect gait and balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Arizona Arthritis Center

Tucson, Arizona, 85713, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneePain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bijan Najafi, PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof

Study Record Dates

First Submitted

June 8, 2015

First Posted

December 3, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2017

Study Completion

June 1, 2017

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations