NCT02116387

Traditional Rehabilitation Versus Rehabilitation With the Imoove® Device for Spinal Musculoskeletal Disorders

Traditional Rehabilitation Versus Rehabilitation With the Imoove® Device for Spinal Musculoskeletal Disorders: a Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to evaluate in patients with chronic low back pain (lasting for more than 3 months and not postoperative) the effect of an instrumental rehabilitation using the I-Moove ® device compared to a conventional physiotherapy rehabilitation for ambulatory postural stability (mean and standard deviation of excursions from the center of gravity) without visual control, 6 weeks after the start of the rehabilitation protocol. We focus on the relative variation between the values obtained on day 0 versus 6 weeks, via measures performed on a force platform. The results will be stratified into 3 age groups (18-39 years, 40-60 years and over 60 years).

Detailed description

The secondary objectives of this study are to evaluate and compare the two physical therapy techniques at 6 weeks and 6 months after the start of the rehabilitation protocol in terms of: A - improving postural stability and visual control on an unstable surface (with and without visual control) B - improving levels of abdominal strength (Ito test) and erector spinae (Sørensen test) C - the impact of back pain on daily life using questionnaires (Dallas, Québec, FABQ and Tampa questionnaires/scores) D - Improvement of pain (Visual Analog Scale),

Conditions

• Lower Back Pain

Interventions

Type	Name	Description
OTHER	Routine Physical Therapy	Patients randomized to this arm will participate in a classic physical therapy program (15 weeks, a total of 15 sessions).
DEVICE	I-Moove Physical Therapy	Patients randomized to this arm will participate in a physical therapy program using the I-Moove device (15 weeks, a total of 15 sessions).

Timeline

• Start date: 2014-07-04
• Primary completion: 2018-06-28
• Completion: 2018-06-28
• First posted: 2014-04-16
• Last updated: 2019-07-05

Locations

2 sites across 1 country: France