Locomotor Training in Individuals With Incomplete Spinal Cord Injury. A Pilot Study

NCT04052009 | Unknown DMC

• 1 other identifier: 2019-00172
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Background: In Switzerland, about 6000 individuals live with the consequences of a spinal cord injury (Brinkhof et al, 2016). One of the major goals after an incomplete spinal cord injury (iSCI) is to regain walking function. To this end, different approaches are used in rehabilitation such as treadmill-based, robotic-assisted (exoskeleton or end-effector) and conventional gait training. According to current literature, the superiority of one of these approaches remains unclear (Mehrholz, Harvey, Thomas, and Elsner, 2017); In the research on gait rehabilitation after iSCI, recent randomized clinical trials (RCTs) found no statistical differences between conventional gait training and robotic-assisted gait training. Nevertheless, according to the comparison of effect sizes obtained from these training, these trials suggested that the conventional training approach leads to larger improvements in gait capacity when compared to robotic-assisted therapy (Field-Fote and Roach, 2011; Nooijen, Ter Hoeve, and Field-Fote, 2009). Therefore, these trials highly recommended further research considering these aspects. However, in clinical settings, the implementation of such systematic and intense training sessions remains challenging. The present study aims to test the hypothesis that conventional training might have larger effect sizes on gait capacity and to evaluate the feasibility of such systematic training in a clinical setting of inpatient rehabilitation. Objectives: To contribute to the current knowledge on best clinical practice in gait rehabilitation within the iSCI population. More specifically, the study objectives are two-fold: A first objective is to compare the effects of conventional training, end-effector based therapy and the combination of these interventions on the gait ability of iSCI. A second objective is the evaluation of the feasibility of systematic gait training protocols in a clinical setting. Participants: Individuals with motor incomplete spinal cord injury (iSCI), presenting a traumatic or non-traumatic iSCI with an injury onset \<6 months. Intervention: Participants will be trained in one of the three groups by trained physical therapists during 10 sessions, 3x/week with an average duration of 30 minutes. Outcomes: To attain the first objective the effects will be quantified by the following main outcomes: Walking capacity (independence), walking speed, and safety. Feasibility of the systematic intervention will be evaluated using the drop-outs of therapy interventions.

Conditions

Incomplete Spinal Cord Injury

Keywords

Spinal cord injury; Gait; Training; Comparison; Robotic-assisted

Outcome Measures

Primary Outcomes (3)

• Change in walking ability

  The capacity to walk independently; This parameter is quantified using the functional ambulatory category (FAC); a 5-points scale (ordinal) to categorize the participant according to its independency in walking (Mehrholz et al, 2007)

  Conducted 2 or 3 days prior to the intervention (Pre-evaluation) and repeated 1-2 days after the last training session of a 2.5 -3 weeks of intervention time. Assessment duration about 2 Minutes.

• Change in walking speed

  Walking speed is quantified using the 10 meter walking test. Therefore the participants have to walk over a 10 meter walkway on level ground. Participants are instructed to walk once at their comfortable speed and once as fast - but save - as possible.

  Conducted 2 or 3 days prior to the intervention (Pre-evaluation) and repeated 1-2 days after the last training session of a 2.5 -3 weeks of intervention time. Assessment duration about 5 Minutes.

• Change in walking security

  Walking security is quantified with the Timed Up and Go Test (Podsiadlo and Richardson, 1991). Therefore participants have to get up from a chair, walk three meters, turn around, walk back to the chair and sit down. The time required to conduct this task is measured. Participants are instructed to walk once at their comfortable speed and once as fast - but save - as possible.

  Conducted 2 or 3 days prior to the intervention (Pre-evaluation) and repeated 1-2 days after the last training session of a 2.5 -3 weeks of intervention time. Assessment duration about 5-10 Minutes.

Secondary Outcomes (1)

• Feasibility of the training protocol

  This outcome is analyzed at the end of the data collection and training sessions by the principal investigator at an estimated time of 15 months after trial start..

Study Arms (3)

CT - Group

EXPERIMENTAL

The conventional training consists of gait training during walking over ground. It includes the standard interventions therapists apply during training over ground. The aim is to achieve as many steps as possible. Three training sessions per week of intensive over ground therapy are planned, and twice a week a therapy with focus of attention isn't walking.

Other: Conventional gait training

EET - Group

ACTIVE COMPARATOR

In the end-effector-based training participants undergo gait training in the end-effector device lyra (THERA-trainer). The principle of an end-effector is that the movement is induced at the level of participants feet. Furthermore, participants wear a harness attached to the end-effector lyra for safety purpose and for weight support. Three training sessions per week of intensive over lyra therapy are planned, and twice a week a therapy with focus of attention isn't walking

Other: End-effector based gait training

CETcomb:

ACTIVE COMPARATOR

The group with the combined training receives 5 sessions of CT and EET each. The pattern of series per week is always either two sessions of CT with one session of EET or vice versa.

Other: combined training (conventional and end-effector-based)

Interventions

Conventional gait training OTHER

Duration and Intensity: 10 sessions of 45 minutes 3-4 times per week Each intervention is conducted by a local physiotherapist For further details please see the description of arms

CT - Group

End-effector based gait training OTHER

Duration and Intensity: 10 sessions of 45 minutes 3-4 times per week Each intervention is conducted by a local physiotherapist For further details please see the description of arms

EET - Group

combined training (conventional and end-effector-based) OTHER

Duration and Intensity: 10 sessions of 45 minutes 3-4 times per week Each intervention is conducted by a local physiotherapist For further details please see the description of arms

CETcomb:

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Incomplete paraplegia or quadriplegia and classification of C and D in the AIS Score from the American Spinal Injury Association (ASIA) (Kirshblum and Waring, 2014).
• The participants should be able to get from a sitting position to a standing position with the aid of an assistant and bars
• Participants need to have a stable cardiovascular condition, absence of known heart disease or a known heart disease classified as class I or II in the New York Heart Association Classification system (American College of Sports Medicine; Guidelines for exercise testing, 2014); medical history is verified by the medical doctor from the SCI ward the REHAB Basel.
• Sufficient compliance for the treatment action
• And have signed the informed consent for the present study

You may not qualify if:

• Patients with an ASIA classification of A and B
• Patients who are unable to stand up from a chair with moderate or no personal assistance
• Patients diagnosed a high-grade osteoporosis
• Patients with severe lower limb movement restrictions (contractions or fractures)
• Known or suspected non-compliance, drug or alcohol abuse,
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

Sponsors & Collaborators

• Rehab Basel: lead

Study Sites (1)

REHAB Basel

Basel, 4055, Switzerland

RECRUITING

Related Publications (12)

• Field-Fote EC, Roach KE. Influence of a locomotor training approach on walking speed and distance in people with chronic spinal cord injury: a randomized clinical trial. Phys Ther. 2011 Jan;91(1):48-60. doi: 10.2522/ptj.20090359. Epub 2010 Nov 4.

  PMID: 21051593 BACKGROUND

• Kirshblum S, Waring W 3rd. Updates for the International Standards for Neurological Classification of Spinal Cord Injury. Phys Med Rehabil Clin N Am. 2014 Aug;25(3):505-17, vii. doi: 10.1016/j.pmr.2014.04.001.

  PMID: 25064785 BACKGROUND

• Levin MF, Hui-Chan C. Are H and stretch reflexes in hemiparesis reproducible and correlated with spasticity? J Neurol. 1993 Feb;240(2):63-71. doi: 10.1007/BF00858718.

  PMID: 8437021 BACKGROUND

• Maher CG, Sherrington C, Elkins M, Herbert RD, Moseley AM. Challenges for evidence-based physical therapy: accessing and interpreting high-quality evidence on therapy. Phys Ther. 2004 Jul;84(7):644-54.

  PMID: 15225083 BACKGROUND

• Mehrholz J, Harvey LA, Thomas S, Elsner B. Is body-weight-supported treadmill training or robotic-assisted gait training superior to overground gait training and other forms of physiotherapy in people with spinal cord injury? A systematic review. Spinal Cord. 2017 Aug;55(8):722-729. doi: 10.1038/sc.2017.31. Epub 2017 Apr 11.

  PMID: 28398300 BACKGROUND

• Mehrholz J, Kugler J, Pohl M. Locomotor training for walking after spinal cord injury. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD006676. doi: 10.1002/14651858.CD006676.pub3.

  PMID: 23152239 BACKGROUND

• Mehrholz J, Wagner K, Rutte K, Meissner D, Pohl M. Predictive validity and responsiveness of the functional ambulation category in hemiparetic patients after stroke. Arch Phys Med Rehabil. 2007 Oct;88(10):1314-9. doi: 10.1016/j.apmr.2007.06.764.

  PMID: 17908575 BACKGROUND

• Nooijen CF, Ter Hoeve N, Field-Fote EC. Gait quality is improved by locomotor training in individuals with SCI regardless of training approach. J Neuroeng Rehabil. 2009 Oct 2;6:36. doi: 10.1186/1743-0003-6-36.

  PMID: 19799783 BACKGROUND

• Musselman KE, Fouad K, Misiaszek JE, Yang JF. Training of walking skills overground and on the treadmill: case series on individuals with incomplete spinal cord injury. Phys Ther. 2009 Jun;89(6):601-11. doi: 10.2522/ptj.20080257. Epub 2009 May 7.

  PMID: 19423643 BACKGROUND

• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 BACKGROUND

• Sandler EB, Roach KE, Field-Fote EC. Dose-Response Outcomes Associated with Different Forms of Locomotor Training in Persons with Chronic Motor-Incomplete Spinal Cord Injury. J Neurotrauma. 2017 May 15;34(10):1903-1908. doi: 10.1089/neu.2016.4555. Epub 2017 Jan 4.

  PMID: 27901413 BACKGROUND

• Street T, Singleton C. A clinically meaningful training effect in walking speed using functional electrical stimulation for motor-incomplete spinal cord injury. J Spinal Cord Med. 2018 May;41(3):361-366. doi: 10.1080/10790268.2017.1392106. Epub 2017 Nov 6.

  PMID: 29108487 BACKGROUND

Related Links

• Website with guidelines for stroke rehabilitation; this actual link refers to the current guideline on rehabilitation best practice for gait recovery. It was used in the introduction of the project.
• This site was used the 03.05.2019 to randomly assign subject numbers to the three treatment groups.

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Martina Betschart, PhD

  Rehab Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martina Betschart, PhD

CONTACT

+41793459610; mbetschart42@gmail.com

Kerstin Hug, MD

CONTACT

+413250000; k.hug@rehab.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessors are blinded since the testing assessor is not conducting the randomization. Patients and the physiotherapists conducting the training are not blinded. This is not due to the training location.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: CT - Group: The conventional training EET: end-effector-based training CETcomb: combined training with CT and EET

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: August 9, 2019
• Study Start: September 24, 2019
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)