Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Prospective, Open label, single arm, non-randomized, non-comparative registry study of Robot-Assisted Physiotherapy Exercises with the REX Robot powered exercise system in patients with Spinal cord or other injury preventing unsupported patient ambulation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation

NCT05615766

Spinal Cord Injuries

RECRUITING NA

Powered Exoskeleton Combined With Functional Electrical Stimulation in Clinical Practice

NCT04568928

Incomplete Spinal Cord Injury

UNKNOWN NA

Robotic Exoskeleton With Functional Electrical Stimulation in Acute Spinal Cord Injury

NCT04250688

Spinal Cord Injuries

UNKNOWN NA

Evaluation of Robotic Exoskeletons Therapy for Gait Rehabilitation in Patients With Incomplete Spinal Cord Injury.

NCT03477123

Spinal Cord Injury Incomplete Spinal Cord Injury

COMPLETED NA

EFFECTS OF ROBOTIC TRAINING ON VASCULAR HEALTH OF INDIVIDUALS WITH SCI

NCT03611803

Exercise Spinal Cord Injuries

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The objective of this feasibility study is to evaluate the overall device safety when used in Spinal Cord Injury Hospitals or Rehabilitation Centers under the supervision of a physician and/or qualified rehabilitation specialists.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rehabilitation using REX

Exercises using Rex mobility assist device

Group Type EXPERIMENTAL

Rehabilitation using REX

Intervention Type DEVICE

Exercises of wheelchair dependent subjects using REX

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rehabilitation using REX

Exercises of wheelchair dependent subjects using REX

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Wheelchair user
* Spinal Injury Levels of C4 down to L5
* Has no outstanding skin integrity issues that could be effected by the REX device
* Should be between approximately 1.42m and 1.93m in height. More specifically, REX is able to accommodate the following limb lengths:
* Upper leg length : 380 - 470 mm
* Lower leg length : 366 - 470 mm
* Heel position (Ankle to hind foot) : 40 - 92 mm
* Floor to ankle height (To be measured while wearing the shoe to be used for mobilising in REX) : 96 - 116 mm
* Has a skeletal hip width of 380 mm or less (limit imposed by REX)
* Is between 40 kg and 100 kg weight (limits imposed by REX)
* Has the manual dexterity to work a joystick
* Sufficient passive range of motion in the Hip, Knee and Ankle of at least
* Hip 90 degrees flexion 15 degrees hip extension 20 degrees abduction 16 degrees adduction
* Knee 0 degrees extension 93 degrees flexion
* Ankle 20 degrees dorsiflexion (with weight bearing and 10 degrees knee flexion) 22 degrees dorsiflexion (with 93 degrees knee flexion) 10 degrees plantar flexion 9 degrees inversion 9 degrees eversion
* Thigh lateral diameter of \< 135 mm (230 mm above the knee joint line)
* Calf lateral diameter of \< 100 mm (90 mm below the knee joint line)
* Manual dexterity to work a joystick with or without a T-Bar and use emergency stop button
* No contraindications to standing or mobilising
* Patients must choose to participate, and must have signed the informed consent document

* Patients with history of impaired cardiac function who have been referred to and reviewed by a medical professional. With a decision made that they should not continue in the trial due to their impaired cardiac function.
* Patients contraindicated to walk or stand
* Withdrawal or refusal to sign informed consent
* Any other contraindication based on physician discretion
* Known allergy (skin contact) to materials used in Rex

Minimum Eligible Age

10 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No