ClinicalTrials.gg
RecruitingNCT07897214FFMUpdated Oct 27, 2026

Comparison Between Objective Biomechanical Cost and Perceived Physical Demand in Manual Wheelchair Users During Propulsion Tasks

An interventional study of Instrumented Manual Wheelchair Propulsion Tasks (Motion Analysis and Instrumented Handrims) and Concurrent Cognitive Task (Auditory-Verbal 2-back) in Manual Wheelchair Use and Spinal Cord Injury, sponsored by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française. Recruiting at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française · Not applicable, Interventional, and Other

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Wheelchair users must be able to move around freely and access public buildings and transport, but current accessibility standards (e.g. maximum 8% ramp slope) are based on limited scientific evidence about the real biomechanical and perceived difficulties encountered by manual wheelchair users in daily life.

Manual wheelchair propulsion is not purely a motor activity: it also involves cognitive and emotional demands (attention, trajectory planning, stress and frustration management) that contribute to a mental workload. This cognitive dimension is still rarely integrated into biomechanical evaluation protocols.

This exploratory (pilot) study aims to test the feasibility of a protocol combining objective biomechanical data (shoulder joint loading estimated from motion capture and instrumented handrims) with the subjective experience of participants (perceived physical demand from the NASA-TLX questionnaire, perceived exertion from the Borg scale), during standardized and more realistic manual wheelchair propulsion tasks, including tasks performed under an added cognitive load (auditory-verbal 2-back dual task).

Read the detailed description

Fifteen manual wheelchair users will be recruited and equipped with reflective motion-capture markers (Qualisys optoelectronic system, 10 cameras) and instrumented handrim wheels (6-axis force sensors) on their own wheelchair. During a single experimental session (maximum 2 hours), participants will perform several propulsion tasks: simple straight-line propulsion, propulsion with a concurrent cognitive task (auditory-verbal 2-back, dual task), propulsion on a ramp (slope below 8%, in line with French accessibility regulations), propulsion on varied floor surfaces, propulsion with turns, and propulsion along a path with an object to reach. Seated posture will be assessed before and after each task with the MCPAA 2.0 clinical scale, heart rate will be monitored with a connected watch, and pain will be checked regularly (participants stop if pain exceeds 7/10).

After each task, participants will rate their perceived physical, mental, temporal, performance, effort and frustration demand using the NASA-TLX questionnaire (French version) and their perceived exertion using the modified Borg (CR10) scale. A qualitative questionnaire will be administered at the end of the session.

Kinematic and kinetic parameters of the upper limb (including estimated shoulder joint loading) will be derived from the motion and force data using biomechanical models of the upper limb. Each participant acts as their own control, so the different experimental conditions are compared within participants. Correlations between the NASA-TLX physical demand subscore, the Borg score and the objective biomechanical shoulder load will be examined using Spearman correlation. As this is a pilot study, analyses will primarily aim to estimate effect sizes, assess protocol feasibility, and explore differences between experimental conditions.

The study is sponsored by the Centre Médico-Chirurgical de Réadaptation (CMCR) des Massues, Croix-Rouge française, and conducted in collaboration with the Laboratoire de Biomécanique et Mécanique des Chocs (LBMC, UMR_T 9406, Université de Lyon), which receives only double-recoded, non-identifying data for biomechanical analysis. The study is funded by the Feed Feel Move project (I-SITE FUTURE).

02

Conditions studied

  • Manual Wheelchair Use
  • Spinal Cord Injury
03

In context

Spinal Cord Injuries

2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.

This study's planned enrollment of 15 is below the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française is the lead sponsor of 12 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Adult participant over 18 years of age
  • Person having signed the form
  • Duration of manual wheelchair use prior to the experiment greater than 2 weeks
  • Ability to perform transfers autonomously, with or without a technical aid
  • Functional criterion: patient who uses the wheelchair autonomously during the day

Non-inclusion Criteria:

  • Refusal of the person to participate or to sign the consent form
  • Diagnosed cognitive disorder
  • Upper limb amputation
  • Refusal of the person to propel the wheelchair bimanually
  • Upper limb injury
  • Average upper limb pain over the past two weeks, on a 0 (no pain) to 10 scale: \< 4
  • Person aged over 70 years
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Manual Wheelchair Propulsion Assessment

    All included participants undergo the full set of instrumented propulsion tasks (simple, dual-task, ramp, varied floor surfaces, turns, object-reaching path) during a single experimental session; each participant is compared to themselves across conditions.

    Other: Instrumented Manual Wheelchair Propulsion Tasks (Motion Analysis and Instrumented Handrims) · Behavioral: Concurrent Cognitive Task (Auditory-Verbal 2-back)

Interventions

  • OtherInstrumented Manual Wheelchair Propulsion Tasks (Motion Analysis and Instrumented Handrims)

    Participants perform standardized manual wheelchair propulsion tasks (straight-line propulsion, propulsion with a concurrent cognitive dual task, propulsion on a ramp, on varied floor surfaces, with turns, and along a path with an object to reach) while equipped with reflective motion-capture markers and using wheels instrumented with 6-axis force sensors on the handrim, in order to estimate biomechanical loading at the shoulder and relate it to subjective measures of perceived demand.

  • BehavioralConcurrent Cognitive Task (Auditory-Verbal 2-back)

    An auditory-verbal 2-back task is added concurrently to a propulsion task (dual task) to examine the effect of cognitive load on propulsion technique and on cognitive performance, compared to single-task propulsion.

06

What researchers measure

Primary outcomes

  1. Correlation Between Perceived Physical Demand (NASA-TLX) and Objective Biomechanical Shoulder Load

    Spearman correlation between the physical demand subscore of the NASA-TLX questionnaire and the biomechanical cost estimated at the shoulder (kinematic and kinetic parameters derived from motion capture and instrumented handrim force data, using an upper-limb biomechanical model), during simple and more physically demanding propulsion tasks (ramp, floor surface change).

    Time frame: During the experimental session (Day 1)

Secondary outcomes

  1. Change in the Correlation Between NASA-TLX Physical Demand Score and Glenohumeral Joint Reaction Force Under Added Mental, Temporal and Performance Demand

    Correlation between two measures, compared between baseline tasks and tasks with added mental, cognitive, temporal, performance and/or frustration demand: Perceived physical demand: score on the Physical Demand subscale of the NASA Task Load Index (NASA-TLX) questionnaire, rated on a 0-20 scale (0 = very low, 20 = very high), completed after each task. Biomechanical load at the shoulder: peak glenohumeral joint reaction force (N), estimated with \[a musculoskeletal model, e.g., OpenSim\] from optoelectronic motion capture data and external forces measured with a six-axis force/torque sensor. Unit of measure: \[Spearman\] correlation coefficient (unitless, range -1 to 1), calculated separately for each task condition. The effect of added demand is assessed as the difference in correlation coefficients between conditions.

    Time frame: During the experimental session (Day 1)

  2. Effect of Dual Task on Shoulder Range of Motion During Wheelchair Propulsion

    Difference in sagittal-plane shoulder flexion/extension range of motion (degrees) between single-task propulsion and dual-task propulsion (propulsion with a concurrent 2-back cognitive task), measured with an optoelectronic motion capture system (Qualysis).

    Time frame: During the experimental session (Day 1)

  3. Effect of Dual Task on Peak Total Force Applied on the Handrim

    Difference in peak total force applied on the handrim (N) between single-task and dual-task propulsion, measured with an instrumented wheelchair wheel.

    Time frame: During the experimental session (Day 1)

  4. Effect of Dual Task on Peak Shoulder Joint Reaction Force

    Difference in peak glenohumeral joint reaction force (N) between single-task and dual-task propulsion, estimated with \[a musculoskeletal model from motion capture and handrim kinetic data.

    Time frame: During the experimental session (Day 1)

  5. Effect of Dual Task on 2-Back Task Accuracy

    Difference in the percentage of correct responses (%) on the 2-back cognitive task between single-task condition (seated, no propulsion) and dual-task propulsion.

    Time frame: During the experimental session (Day 1)

  6. Effect of Dual Task on 2-Back Task Reaction Time

    Difference in mean reaction time (ms) for correct responses on the 2-back cognitive task between single-task condition and dual-task propulsion.

    Time frame: During the experimental session (Day 1)

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Oct 2026, 0 months after the start.

Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 0 months is below that.

Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2026
First posted
Oct 27, 2026
StartActual
Oct 19, 2026
Primary completionEst.
Oct 23, 2026
CompletionEst.
Oct 23, 2026
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07897214
Lead sponsor
Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
Responsible party
Sponsor
First posted
Oct 27, 2026
Start date
Oct 19, 2026
Primary completion
Oct 23, 2026 (estimated)
Completion
Oct 23, 2026 (estimated)
Last update
Oct 27, 2026

Study contacts

Julie Rozaire
Contact
julie.rozaire@croix-rouge.fr
+33 4 72 38 11 43
Laura Boutevillain, MD
Contact
laura.boutevillain@croix-rouge.fr
+33 4 72 38 62 93

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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