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

NCT06097000 | Recruiting

• 1 other identifier: XW-NS-IPEPSR
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Exoskeleton Device

Keywords

Hip Exoskeleton Device; Spinal Cord Injuries; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Six-minute walk test

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

  3 months

Secondary Outcomes (12)

• Average rate of change in muscle strength

  3 months

• 10 meter autonomous walking test

  3 months

• 10 meter fast walking test

  3 months

• rate of change in hip joint mobility

  3 months

• stride length

  3 months

Study Arms (2)

Powered Exoskeleton Group

EXPERIMENTAL

Rehabilitation exercises with powered exoskeletons

Device: powered exoskeletons

Traditional Group

NO INTERVENTION

Rehabilitation exercises without the use of powered exoskeletons

Interventions

powered exoskeletons DEVICE

Whether to use powered exoskeletons for exercise rehabilitation

Powered Exoskeleton Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• BEIJING DNSYS INNOVATION Co. Ltd: collaborator
• Beijing Haidian Hospital: collaborator

Study Sites (1)

Intelligent Powered Exoskeleton

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Wanru Duan

CONTACT

13581803400; duanwanru@xwhosp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 24, 2023
• Study Start: October 20, 2023
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

CN (1)