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

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

Interventions

OTHER

Conventional gait training

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

OTHER

End-effector based gait training

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

OTHER

combined training (conventional and end-effector-based)

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

Sponsors & Collaborators

• Rehab Basel

  lead OTHER

Principal Investigators

• Martina Betschart, PhD · Rehab Basel

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-24

Primary Completion

2020-06-01

Completion

2020-12-01

Countries

• Switzerland

Study Locations