Manual Wheelchair UseFFMNCT07897214
Comparison Between Objective Biomechanical Cost and Perceived Physical Demand in Manual Wheelchair Users During Propulsion Tasks
A study testing Instrumented Manual Wheelchair Propulsion Tasks (Motion Analysis and Instrumented Handrims) and Concurrent Cognitive Task (Auditory-Verbal 2-back) in people with Manual Wheelchair Use and Spinal Cord Injury, run by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Manual Wheelchair Use, Spinal Cord Injury
- What is being tested?
- Instrumented Manual Wheelchair Propulsion Tasks (Motion Analysis and Instrumented Handrims) and Concurrent Cognitive Task (Auditory-Verbal 2-back)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2026to 23 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participant over 18 years of age
- Person having signed the informed consent 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:
Show all 13Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Médico-Chirurgical de Réadaptation des Massues
Lyon, 69005
Julie Rozaire, +33 4 72 38 11 43, julie.rozaire@croix-rouge.fr
Laura Boutevillain, MD, +33 4 72 38 62 93, laura.boutevillain@croix-rouge.fr
About this study
Official title: Comparison Between an Objective Biomechanical Cost and the Physical Perception of a Manual Wheelchair User During Propulsion Tasks
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).
- Conditions
- Manual Wheelchair Use, Spinal Cord Injury
- Being tested
- Instrumented Manual Wheelchair Propulsion Tasks (Motion Analysis and Instrumented Handrims), Concurrent Cognitive Task (Auditory-Verbal 2-back)
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrumented Manual Wheelchair Propulsion Tasks (Motion Analysis and Instrumented Handrims)Other
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.
Concurrent Cognitive Task (Auditory-Verbal 2-back)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Manual Wheelchair Propulsion Assessment | Experimental | 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. Receives: Other: Instrumented Manual Wheelchair Propulsion Tasks (Motion Analysis and Instrumented Handrims); Behavioral: Concurrent Cognitive Task (Auditory-Verbal 2-back) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the experimental session (Day 1)
Secondary outcomes (6)
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.
Measured: During the experimental session (Day 1)
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).
Measured: During the experimental session (Day 1)
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.
Measured: During the experimental session (Day 1)
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.
Measured: During the experimental session (Day 1)
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.
Measured: During the experimental session (Day 1)
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.
Measured: During the experimental session (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start19 Oct 2026
- Primary completion23 Oct 2026 (estimated)
- Study completion23 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Manual Wheelchair UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Exploratory (pilot) single-group study; each participant serves as their own control, with all experimental propulsion conditions compared within participants.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897214
- Sponsor's protocol ID
- 2026_04_FFM_RIPH2
- Other IDs
- 2026-A01074-47
- Acronym
- FFM
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between an Objective Biomechanical Cost and the Physical Perception of a Manual Wheelchair User During Propulsion Tasks
- ClinicalTrials.gov ID
- NCT07897214
- Acronym / sponsor ID
- FFM / 2026_04_FFM_RIPH2
- Conditions
- Manual Wheelchair Use, Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge FrançaiseUniversity, hospital or other
- Study start
- 19 Oct 2026 (actual)
- Primary completion
- 23 Oct 2026 (estimated)
- Study completion
- 23 Oct 2026 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Exploratory (pilot) single-group study; each participant serves as their own control, with all experimental propulsion conditions compared within participants.
| Arm | Type | Receives |
|---|---|---|
| Manual Wheelchair Propulsion Assessment | Experimental | Other: Instrumented Manual Wheelchair Propulsion Tasks (Motion Analysis and Instrumented Handrims), Behavioral: Concurrent Cognitive Task (Auditory-Verbal 2-back)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult participant over 18 years of age
- Person having signed the informed consent 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instrumented 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. | Other | Manual Wheelchair Propulsion Assessment |
| Concurrent 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. | Behavioural | Manual Wheelchair Propulsion Assessment |
Primary outcome
Correlation Between Perceived Physical Demand (NASA-TLX) and Objective Biomechanical Shoulder Load
Time frame: During the experimental session (Day 1)
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).
6 secondary outcomes
Change in the Correlation Between NASA-TLX Physical Demand Score and Glenohumeral Joint Reaction Force Under Added Mental, Temporal and Performance Demand
Time frame: During the experimental session (Day 1)
Effect of Dual Task on Shoulder Range of Motion During Wheelchair Propulsion
Time frame: During the experimental session (Day 1)
Effect of Dual Task on Peak Total Force Applied on the Handrim
Time frame: During the experimental session (Day 1)
Effect of Dual Task on Peak Shoulder Joint Reaction Force
Time frame: During the experimental session (Day 1)
Effect of Dual Task on 2-Back Task Accuracy
Time frame: During the experimental session (Day 1)
Effect of Dual Task on 2-Back Task Reaction Time
Time frame: During the experimental session (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrumented Manual Wheelchair Propulsion Tasks (Motion Analysis and Instrumented Handrims) and Concurrent Cognitive Task (Auditory-Verbal 2-back) in people with Manual Wheelchair Use and Spinal Cord Injury, run by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Rozaire (+33 4 72 38 11 43, julie.rozaire@croix-rouge.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Perceived Physical Demand (NASA-TLX) and Objective Biomechanical Shoulder Load (time frame: During the experimental session (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.