Clinical Evaluation of Instrumented Wheel as Biomedical Device Quantifying the Displacement Efficiency

NCT ID: NCT01935687

Last Updated: 2017-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-07-31

Brief Summary

The purpose of this study is to validate an instrumented wheel such as a new biomedical device. The physicians will compare this instrumented wheel with another instrumentation "Ergometer roller", each patient will try the both instrumentations, physical and physiological parameters will be measured.

The increase rate of radial power during the cardiac stress test may be more important when the physicians use the instrumented wheel.

Detailed Description

• The manual wheelchair is used by people for whom walking is difficult or impossible due to spinal cord lesions, neurological and muscular diseases, lower limb trauma, age …etc.

Although the wheelchair help to regain mobility, this made of displacement is nor natural nor well-to-do.

• The CIC-IT and TSR (Transmissions Services Roulements, Mérignac, France) improved the instrumented wheel, adaptable with all wheelchairs, with information wireless transmission.
• The primary objective of study is to validate the instrumented wheel of manual wheelchair such as a new device of evaluation of capacities of displacement in ecologic situation.
• The primary criteria is to compare the mechanical power calculated using instrumented wheel versus the power calculated using ergometer roller during protocol of standard cardio-respiratory stress test.

This study is interventional, mono-centric, controlled and crossover. The population concerned is patients with spinal cord injury (SCI) and users of manual wheelchair.

Number of subjects projected for the entire study: 62 patients The total duration of participation of each patient: 7 days ±2days

Conditions

Spinal Cord Injury

Keywords

Instrumented Wheel; Manual Wheelchair; Spinal Cord Injury (SCI); Manual wheelchair Users; Aged between 18-70 years

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Using of instrumented wheel and ergometer roller

The same patient will receive two types of tests: instrumented wheel and ergometer roller.

Group Type: EXPERIMENTAL

Using of instrumented wheel

Intervention Type: DEVICE

Using of instrumented wheel

Using of ergometer roller

Intervention Type: DEVICE

Using of ergometer roller

Interventions

Using of instrumented wheel

Using of instrumented wheel

Intervention Type: DEVICE

Using of ergometer roller

Using of ergometer roller

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age : 18-70 years.
• Spinal cord injured patient.
• User of manual wheelchair for daily locomotion (having at least 30/100 at displacement items of WST questionnaire) .
• Affiliation to a social security scheme or entitled.
• Informed consent dated and signed by subject or subject's legally acceptable representative (and investigator).

Exclusion Criteria

• Cognitive troubles.
• Progressive diseases: Tumoral, infectious, inflammatory and associated pathologies: brain injury, amputation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Djamel Bensmail, MD

Role: PRINCIPAL_INVESTIGATOR

Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France

Locations

Djamel Bensmail

Garches, Hauts-de-Seine, France

Countries

France

Other Identifiers

P101006

Identifier Type: -

Identifier Source: org_study_id