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Vibrotactile Feedback in Exoskeletons

S

Sint Maartenskliniek

Status

Completed

Conditions

Spinal Cord Injuries

Treatments

Other: Vibrotactile feedback

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06306352
NL82999.091.22 (Other Identifier)
1070

Details and patient eligibility

About

This study aims to investigate the impact of providing discrete vibrotactile feedback related to weight shift and step initiation on exoskeleton use in individuals with motor-complete SCI.

Full description

Rationale: People with motor-complete spinal cord injury (SCI) lack motor function below the lesion level and are, thus, wheelchair-dependent. In recent years, wearable exoskeletons have emerged as potential mobility devices for this population. Although exoskeletons generate the basic motions for ambulation, postural stability must be maintained by the user. People with motor-complete SCI miss essential somatosensory perception, which affects their ability to maintain postural stability. Hence, walking in an exoskeleton is demanding, and crutches are necessary.

When sensory information of a specific system is lost, the lack of sensory information can be substituted by providing feedback to another sensory system. As sensory feedback has been shown to improve postural control in people missing essential sensory information, such sensory substitution may also be effectively incorporated in people with complete SCI using an exoskeleton.

Objective: The study aims to investigate the effect of vibrotactile feedback on exoskeleton use in people with motor-complete SCI.

Study design: The proposed study is an experimental study. The study protocol includes six sessions of 90 minutes spread over three weeks. Sessions one to five are dedicated to training to assess the effect of vibrotactile feedback on exoskeleton motor learning. Session six is dedicated to evaluation to assess the effect of vibrotactile feedback on exoskeleton motor control.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • SCI classification American Spinal Injury Association Impairment Scale (AIS) A or B
  • Minimally six months post-injury
  • Prior experience with the ReWalk Exoskeleton, able to walk independently

Exclusion criteria

  • Pre-existing somatosensory problems before the SCI
  • Visual or auditory issues that are not resolved with glasses or a hearing device
  • Insufficient mastery of the Dutch language
  • Contraindications related to the ABLE Exoskeleton

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 1 patient group

Vibrotactile feedback
Experimental group
Description:
Participants will receive vibrotactile feedback in the ABLE Exoskeleton.
Treatment:
Other: Vibrotactile feedback

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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