NCT02503410

An Interactive Gaming-based Intervention for Back Pain

Augmenting Back Pain Exercise Therapy Using an Interactive Gaming-based Intervention in the Home Setting

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Spaulding Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare the outcomes of a traditional, exercise-based rehabilitation intervention for chronic low back pain with the outcomes achieved by combining a traditional intervention with adjunct therapy delivered using an interactive gaming-based system for home-based therapy.

Detailed description

The study relies upon the Valedo system by Hocoma AG to implement an interactive gaming-based intervention (i.e. subjects receive part of their physical therapy by playing interactive video games). The system is similar to consumer electronics products for interactive gaming that track the subject's movements using body-worn sensors. The FDA has determined that the Valedo system is a 510(K) exempt device under the product code ION (i.e. exerciser, non-measuring device for Physical Medicine). In the study, subjects with non-specific chronic low back pain are randomized using a block design to one of two groups: group 1 receives usual care alone; group 2 receives an exercise-based rehabilitation intervention using interactive gaming in addition to usual care. Clinical assessments are performed at baseline and again 4 weeks and 8 weeks after baseline measures are gathered.

Conditions

• Non-specific Chronic Low Back Pain

Interventions

Type	Name	Description
BEHAVIORAL	Usual care	Subjects receive standard physical therapy, including outpatient visits as prescribed by the treating clinician and home-based exercises based on recommendations by the physical therapist.
BEHAVIORAL	Interactive gaming	Subjects receive a combination of standard physical therapy in the clinic and home-based exercises that they perform using the Valedo system.

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2015-07-21
• Last updated: 2019-05-28
• Results posted: 2019-05-28

Locations

1 site across 1 country: United States