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NCT Number: NCT06097000

A Study of the Safety and Efficacy of Intelligent Powered Exoskeletons in Postoperative Spinal Rehabilitation

Systematic and professional rehabilitation training is generally effective for patients with lower limb dyskinesia, but most of them lose the chance of recovery due to failure to receive systematic rehabilitation treatment. Our team has developed an intelligent power armor for patients with lower limb motor dysfunction, which can assist patients to complete high-quality rehabilitation training. In order to evaluate the safety and efficacy of the Smart Power Armor for post-surgical spine patients, and to provide data support for a confirmatory clinical study, we designed a single-center, prospective, randomized controlled study to compare the level of recovery of lower limb motor function in patients with different rehabilitation strategies.

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Key information

Conditions

Exoskeleton Device Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intelligent Powered Exoskeleton

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Wanru Duan, Associate Professor

CONTACT

[email protected]

(+86)13581803400

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-70 years old;
  • Spinal surgery within 1 year due to degeneration, tumor, trauma or other reasons, postoperative motor disorders of both lower limbs, such as muscle weakness (3-5 level reduction), increased muscle tone, gait incoordination caused by deep sensory loss, etc.;
  • The patient does not have a plan to rehabilitate in a specialized rehabilitation hospital, and plans to rehabilitate at home;

Exclusion criteria

  • Short expected survival from malignant diseases;
  • Muscle strength is less than grade 3, and the muscles of both lower limbs are severely atrophied;
  • Suffering from other neurological diseases;
  • Planned to undergo other surgeries within 3 months;
  • Unable to cooperate with the transmission power external armor or cooperate with the rehabilitation training due to the physical condition;

Treatment and study plan

powered exoskeletons

Device

Whether to use powered exoskeletons for exercise rehabilitation

Primary outcomes

  1. Six-minute walk test

    Time frame: 3 months

    meter; distance participants walked as fast as possible in a flat corridor in six minutes

Secondary outcomes

  1. Average rate of change in muscle strength

    Time frame: 3 months

    (change in muscle strength level* number of persons)/total number of persons enrolled in the group

  2. 10 meter autonomous walking test

    Time frame: 3 months

    meter; participants walk ten meters at a self-selected speed

  3. 10 meter fast walking test

    Time frame: 3 months

    meter; participants walk ten meters at fastest speed

  4. rate of change in hip joint mobility

    Time frame: 3 months

    (hip joint mobility with assistance - hip joint mobility without assistance)/hip joint mobility without assistance; use joint mobility scales to measure hip joint mobility

  5. stride length

    Time frame: 3 months

    centimeter; left and right legs are measured separately

  6. rate of change in heart rate

    Time frame: 3 months

    (post-training heart rate - resting heart rate)/resting heart rate

  7. rate of change in arterial partial pressure of oxygen

    Time frame: 3 months

    (post-training arterial partial pressure of oxygen - arterial partial pressure of oxygen at rest)/arterial partial pressure of oxygen at rest

  8. adverse event incidence rate

    Time frame: 12 months

    Number of cases of adverse events/number of enrollees

  9. serious adverse event incidence rate

    Time frame: 12 months

    Number of cases of serious adverse events/number of enrollees

  10. Thigh Swing Speed

    Time frame: 3 months

    degrees/second; left and right legs are measured separately

  11. Thigh Lifting Moment

    Time frame: 3 months

    Newton*Meter; left and right legs are measured separately

  12. Thigh Swing Angle

    Time frame: 3 months

    degree; left and right legs are measured separately

Study contacts

Contact information is provided by the study sponsor or research team.

Wanru Duan

CONTACT

[email protected]

13581803400

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

  • BEIJING DNSYS INNOVATION Co. Ltd
  • Beijing Haidian Hospital

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 24, 2023
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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