Recruiting

Exoskeletons

Sponsor:

TOPMED

Code:

NCT07084974

Conditions

Exoskeleton Device

Eligibility Criteria

Sex: Male

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Adjustment and practice session

No trunk assistance

Uplift Lite exoskeleton

Biolift exoskeleton

Laevo Flex exoskeleton

Study Details

Brief summary:

The goal of this interventional study is to evaluate the effect of three different designs of trunk assistance exoskeletons on cumulative lumbar load, trunk extensors' muscular fatigue and comfort in healthy volunteers. The main questions it aims to answer is: will exoskeletons reduce muscle fatigue and cumulative lumbar load. Participants will :

  • get each exoskeletons adjusted and then practice the lifting task and measurement sequence in a first session
  • perform a lifting task for 4 blocks of 20 minutes on different sessions for each exoskeleton, another session is performed without assistance.

Conditions

Exoskeleton Device

Study ID

NCT07084974

Start date

Jun 4, 2025

Status verified date

Jul, 2025

Completion date

May 1, 2026

Anticipated

Primary completion date

Nov 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Being able to communicate in french

Exclusion Criteria:

  • Back pain in the last year
  • Back pain for more than a week in the years prior
  • Musculoskeletal injury in the last year
  • Trunk musculoskeletal system surgery in the last year
  • Scoliosis diagnostic
  • Systemic illness, degenerative disease or syndrome related to the trunk musculoskeletal or nervous system
  • Body mass index over 35 kg/m\^2
  • History of neurological damage
  • Any contraindication to the practice of physical activity
  • Incapacity to perform the lifting task at the specified rythm
  • Medication with a negative impact on balance

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Repeated measures intervention group

Participants will perform 5 different intervention sessions:

An adjustment and practice session which is always performed first, then participants will performed 4 lifting tasks sessions in randomized order:

  • No trunk assistance session
  • Uplift Lite exoskeleton session
  • Biolift exoskeleton session
  • Laevo Flex exoskeleton session

During each lifting task session, participants will perform 3 blocks of 20 minutes of the lifting task. The lifting task is a box transfer tasks from the ground to a table adjusted at hip height. The task rythm is 7 cycles per minute. The box weight is equivalent to 10% of their maximal lifting strength. The handles of the box are positioned at 28 cm above the bottom of the box. Total session duration is about 3 hours for all sessions. Participants will have between 4 and 14 days of rest in between each sessions.

Interventions

Adjustment and practice session

During the adjustment and practice session, participants will perform the lifting task with each exoskeleton after they are properly fitted. They will also perform the measurement sequence as to limit learning effects during lifting task sessions. The lifting task is a box transfer tasks from the ground to a table adjusted at the participant's hip height. The task rhythm is 7 cycles per minute. The box weight is equivalent to 10% of their maximal lifting strength. Total session duration is about 3 hours.

No trunk assistance

This lifting task session is performed without any trunk assistance exoskeleton. Participants perform 3 blocks of 20 minutes of the lifting task. The lifting task is a box transfer tasks from the ground to a table adjusted at the participant's hip height. The task rhythm is 7 cycles per minute. The box weight is equivalent to 10% of their maximal lifting strength. Total session duration is about 3 hours.

Uplift Lite exoskeleton

This lifting task session is performed with the Mawashi Uplift Lite trunk assistance exoskeleton. Participants will perform 3 blocks of 20 minutes of the lifting task. The lifting task is a box transfer tasks from the ground to a table adjusted at the participant's hip height. The task rhythm is 7 cycles per minute. The box weight is equivalent to 10% of their maximal lifting strength. Total session duration is about 3 hours.

Biolift exoskeleton

This lifting task session is performed with the Biolift trunk assistance exoskeleton. Participants perform 3 blocks of 20 minutes of the lifting task. The lifting task is a box transfer tasks from the ground to a table adjusted at the participant's hip height. The task rhythm is 7 cycles per minute. The box weight is equivalent to 10% of their maximal lifting strength. Total session duration is about 3 hours.

Laevo Flex exoskeleton

This lifting task session is performed with the Leavo Flex trunk assistance exoskeleton. Participants perform 3 blocks of 20 minutes of the lifting task. The lifting task is a box transfer tasks from the ground to a table adjusted at the participant's hip height. The task rhythm is 7 cycles per minute. The box weight is equivalent to 10% of their maximal lifting strength. Total session duration is about 3 hours.

Primary outcome measure

  • Change in spinal compression [ Time Frame: For each lifting task session, change between session's baseline(immediately before the first lifting task block) and immediately after each lifting task block ]
  • Change in muscular exertion perception [ Time Frame: For each lifting task session, change between session's baseline(immediately before the first lifting task block) and immediately after each lifting task block ]
  • Change in maximal lifting strength [ Time Frame: For each lifting task session, change between session's baseline(immediately before the first lifting task block) and immediately after the last lifting task block ]

Central Contacts and Locations

Central contacts

Edith Martin, Ph.D

4187801301emartin@topmed.ca

Gabriel Diamond Ouellette, Ph.D

gdiamondouellette@topmed.ca

Locations

TOPMED

Recruiting

Québec, Quebec, Canada, G1S1C1

Contacts

Edith Martin, Ph.D

4187801301emartin@topmed.ca

Gabriel Diamond Ouellette, Ph.D

gdiamondouellette@topmed.ca

More Information

Sponsor

TOPMED

Last update posted

Jul 25, 2025

Last verified

Jul, 2025

Keywords

  • exoskeleton
  • trunk assistance
  • cumulative lumbar load
  • muscular fatigue
  • lifting task
  • comfort
  • acceptability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by TOPMED on 2025-07-25.