Recruiting

Observational Study

Sponsor:

The London Spine Centre

Code:

NCT03337178

Conditions

Lumbar Degenerative Spinal Stenosis

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Blinded Fitbit

Fitbit

Study Details

Brief summary:

Spinal stenosis is a common orthopedic spine condition that limits individuals ability to walk and stand because of nerve compression. Surgical treatment can alleviate leg pain and improve function such as increasing physical activity. This study will use Fitbit technology to monitor patient's post-operative physical activity. It will evaluate the efficacy of a Fitbit incentive based walking program on improving post-operative physical activity and rehabilitation.

Conditions

Lumbar Degenerative Spinal Stenosis

Study ID

NCT03337178

Start date

Aug 1, 2018

Status verified date

Aug, 2020

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Aug 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 60 years of age and older
  • diagnosed with neurogenic claudication or radiculopathy secondary to central or lateral recess stenosis between L3-L5 confirmed by CT or MRI
  • consent for surgical treatment

Exclusion Criteria:

  • traumatic stenosis from a pathologic fracture
  • inflammatory spine disease
  • peripheral arterial disease
  • hip or knee arthritis or pulmonary or circulatory diseases for which exercise is contraindicated
  • severe or progressive neurologic deficit effecting ambulatory ability
  • cancer
  • no access to a computer or mobile device
  • inability to complete the questionnaires or provide follow-up (i.e. lack of permanent address, substance abuse, interfering psychiatric illness).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Control

Standard of care

experimental: Blinded Fitbit

Blinded Fitbit, no step goal, and no activity feedback

experimental: Fitbit

Fitbit plus step goal and activity feedback

Interventions

Blinded Fitbit

Fitbit is worn for 3 months post-operatively with no activity feedback or step goals

Fitbit

Fitbit is worn for 3 months post-operatively with feedback and step goals

Primary outcome measure

  • Self-Paced Walking Test [ Time Frame: Change in 3 months post-op from baseline ]

Central Contacts and Locations

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6G 5L7

Contacts

Christopher S Bailey, MD

519-685-8500Chris.Bailey@lhsc.on.ca

Principal Investigator:

Christopher S Bailey, MD

More Information

Sponsor

The London Spine Centre

Last update posted

Aug 21, 2020

Last verified

Aug, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The London Spine Centre on 2020-08-21.