Retest-reliability and At-home-assessment Feasibility of the 5R-STS

Completed

• Conditions: Degenerative Disc Disease; Spinal Stenosis Lumbar; Spondylolisthesis; Spondylosis; Herniated Nucleus Pulposus; Spinal Diseases; Spinal Instability

• Registration Number: NCT03321357
• Lead Sponsor: Bergman Clinics

Brief Summary

The five-repetition sit-to-stand test has been validated and is used primarily in pulmonary medicine and cardiology, and has recently been shown to be a useful tool for the objective assessment of functional impairment in patients with degenerative diseases of the lumbar spine.

The goal of this study is to assess the possibility of supervised and unsupervised at-home-assessment. Validation of at-home-assessment would allow the 5R-STS to be easily used as a follow-up tool in clinical trials, for example.

Detailed Description

Patients will perform three 5R-STS measurements:

1. During outpatient clinics, time measured by the physician

2. At home, time measured by partner/family

3. At home, and assessed by producing a video recording of the 5R-STS performance that is subsequently sent and analyzed (time measured digitally)

Study Timeline

• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-25
• Study Start: 2017-12-08
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-21
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-12
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Degenerative diseases of the lumbar spine (Herniated disc, lumbar stenosis, spondylolisthesis, degenerative disc disease)
• Symptoms of lower back pain, neurogenic claudication, or radiculopathy

Exclusion Criteria

• Hip or Knee prosthetics
• Walking aides

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5R-STS	0 months	Objective functional test measuring the amount of functional impairment.

Secondary Outcome Measures

Name	Time	Method
EQ-5D-3L	0 months	Validated questionnaire measuring quality of life
VAS leg pain severity	0 months	Validated questionnaire measuring pain
Oswestry Disability Index	0 months	Validated questionnaire measuring functional disability
VAS back pain severity	0 months	Validated questionnaire measuring pain
Roland Morris Disability Questionnaire	0 months	Validated questionnaire measuring functional disability

Trial Locations

Locations (1)

Bergman Clinics; 🇳🇱 Naarden, Netherlands