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

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Device: Using of instrumented wheel; Device: Using of ergometer roller

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

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Hauts-de-Seine
    • Garches, Hauts-de-Seine, France, 92380
      • Djamel Bensmail

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Using of instrumented wheel and ergometer roller; The same patient will receive two types of tests: instrumented wheel and ergometer roller.	Device: Using of instrumented wheel; Using of instrumented wheel; Device: Using of ergometer roller; Using of ergometer roller

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical power calculated by instrumented wheel and ergometer roller.	Comparison between mechanical power calculated by the instrumented wheel and mechanical power calculated by ergometer roller.	20 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficient fraction of total power calculated using instrumented wheel	Tangential power / total power	6 min
Efficient fraction of total power calculated using ergometer roller	Tangential power / total power	15 min

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological parameters using instrumented wheel	Heart rate, VO2 and Borg score.	6 min
Physiological parameters using ergometer roller	Heart rate, VO2 and Borg score.	15 min

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Djamel Bensmail, MD, Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: March 4, 2013
• First Submitted That Met QC Criteria: September 2, 2013
• First Posted (Estimate): September 5, 2013

Study Record Updates

• Last Update Posted (Actual): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 17, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Spinal Cord Injury (SCI); Manual Wheelchair; Aged between 18-70 years; Instrumented Wheel; Manual wheelchair Users
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: P101006