ROBERT® as an Intervention to Enhance Muscle Strength After Spinal Cord Injury

NCT05558254 | Active Not Recruiting

• 1 other identifier: ROBERT
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal cord injury (SCI) is a devastating life event with long term consequences both physically and mentally. SCI is defined as either complete or incomplete according to the International Standards of the Neurological Classification of SCI. The primary consequence of a SCI is paralysis/partial paralysis affecting the person's ability to independently functioning in everyday life e.g. in and out of bed, sit to stand and walking. To regain the ability to transfer and walk the most important prerequisite is to rebuild as much strength as possible in the lower extremities. The optimal training paradigm to increase strength in partial paralysed muscles is unclear. Rehabilitation robots are upcoming methods to treat sensorimotor deficits after SCI. The rehabilitation robot ROBERT might contribute to enhance muscle strength for people with very weak strength following an incomplete SCI. The overall objective of this Ph.D project is to investigate the feasibility and effect size of a muscle strength training intervention assisted by ROBERT® for patients with SCI and severe paresis (muscle strength 1-3 in hip flexion).

Conditions

Spinal Cord Injuries

Keywords

Spinal cord injuries; Pilot study; robot; muscle strength

Outcome Measures

Primary Outcomes (1)

• Change in Muscle strength in Newton

  Change in maximal voluntary contraction (MVC) in isometric muscle strength (N) of hip flexion (8 weeks - baseline)

  At baseline and at 8 weeks

Secondary Outcomes (7)

• Chance in EMG activity

  At baseline and at 8 weeks

• Change in repetitions

  At baseline and at 8 weeks

• Difference between legs in numbers of hip flexion

  At 4 weeks

• Change in spasticity

  At baseline and at 8 weeks

• Change in muscle thickness

  At baseline and at 8 weeks

Other Outcomes (1)

• Acceptability and suitability of the intervention - patients' perspective

  At 8 weeks

Study Arms (2)

ROBERT

ACTIVE COMPARATOR

The intervention group will receive usual practice. As add-on, the intervention leg will receive 3-4 sets of 15-20 repetitions (30 seconds rest between each set) of muscle strength training for hip flexion with ROBERT® three times a week.

Other: Robert - intervention to enhance muscle strength

Control

NO INTERVENTION

Usual practice in the control group consist of 3-5 times physiotherapy a week for 8 weeks. A session last 45 minutes. The sessions are individually adapted and can contain exercise therapy, functional training, assistive devices, electrical stimulation, hydrotherapy and tread mill training.

Interventions

Robert - intervention to enhance muscle strength OTHER

Intervention: Training will be conducted with the robot ROBERT®. 3 times a week for 8 weeks the patient will conduct 60 repetitions of hip flexion of one leg. The patient is lying supine. ROBERT is attached to the patient's lower leg. The physiotherapist guides the patient's leg in hip flexion and ROBERT record the movement. The ROBERT is attached to the patient's lower leg and thereby eliminating the gravity of the leg. The physiotherapist guides the patient's leg in hip flexion and ROBERT record the movement. ROBERT is set in active or guided mode and will be individually adjusted. When practice starts the patient get visual feedback to the range of movement of the hip flexion plus the amount of repetitions conducted and persisting.

ROBERT

Eligibility Criteria

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

You may qualify if:

• SCI (\< 12 month),
• Age ≥ 18 year
• Muscle strength 1 - 3 in hip flexion in both legs measured by manual muscle testing.
• Sufficient Danish or English to be able to provide informed consent

You may not qualify if:

• Previous cerebral injury or SCI
• Previous damage to peripheral nervous system in lower extremities
• Instable fractures in thorax or lower extremities
• Muscle strength 0, 4 or 5 in hip flexion
• Weight \> 150 kg

Sponsors & Collaborators

• Spinal Cord Injury Centre of Western Denmark: lead
• Svend Andersen Fonden: collaborator

Study Sites (1)

Spinal Cord Injury Centre of Western Denmark

Viborg, Central Jutland, 8800, Denmark

Location

Related Publications (3)

• Sorensen SL, Poulsen I. Patients' and physiotherapists' experiences with robotic technologies for lower extremity rehabilitation following spinal cord injury: a reflexive thematic analysis. Disabil Rehabil. 2025 Oct 17:1-14. doi: 10.1080/09638288.2025.2573170. Online ahead of print.

  PMID: 41105483 DERIVED

• Lillelund Sorensen S, Lipperts M, Nielsen JF, Naess-Schmidt E. Clinical validation of a rule-based decision tree algorithm for classifying hip movements in people with spinal cord injury. J Spinal Cord Med. 2025 Mar 31:1-10. doi: 10.1080/10790268.2025.2472096. Online ahead of print.

  PMID: 40163036 DERIVED

• Sorensen SL, Poulsen I, Harvey LA, Biering-Sorensen F, Nielsen JF. Robotic technology (ROBERT(R)) to enhance muscle strength in the hip flexor muscles following spinal cord injury: a feasibility study. Spinal Cord Ser Cases. 2024 Apr 10;10(1):20. doi: 10.1038/s41394-024-00630-9.

  PMID: 38600074 DERIVED

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

Study Officials

• Susanne Lillelund, MSc, PT

  Spinal Cord Injury Centre of Western Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization is performed after baseline assesment. The outcomes assessor will be blinded to treatment/control group at follow-up assesment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patient's legs will be randomised to either training with ROBERT® or usual training (control)

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: September 28, 2022
• Study Start: September 21, 2022
• Primary Completion: May 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)