Effect of assisted walking-movement in patients with genetic and acquired neuromuscular disorders with the motorised Innowalk device: an international case study meta-analysis

Abstract

People with physical disabilities (PD) suffer from consequences due to lack of physical activity and consequently, are at increased risk of chronic diseases. We aimed to evaluate the ability of a motorised assistive device for dynamic standing with weight-bearing in addition to standard state-of-the-art therapy to improve clinical outcome in a meta-analysis of available studies. A total of 11 studies were identified from different European countries analysing the effect of the dynamic device Innowalk. Raw data of nine studies were pooled including a total of 31 patients observed between 2009 and 2017. Standardised questionnaires and physical outcomes were examined in this exploratory meta-analysis. We recorded patients' characteristics, duration, intensity, and location of usage as well as general clinical outcomes and improvement of passive range of motion (PROM). The analysed population consisted in 90% cases of patients younger than 18 years of age. Patients were severely disabled individuals (aged 8 (6-10) years; 58% male; 67% non-ambulatory, 86% cerebral palsy). A total of 94% used the Innowalk in a home-based or day-care setting. For nearly all individuals (94%), improvements were recorded for: walking or weight-bearing transfer (n = 13), control/strength of the trunk or head (n = 6), joint mobility (n = 14), sleep (n = 4 out of 6/67%), or muscle strength (n = 17), vital functions (n = 16), bowel function (n = 10), attention/orientation (n = 2). PROM of the hip (flexion, abduction, and adduction) significantly (p < 0.001 for multiple comparisons) increased after 1 month (p < 0.05 flexion, adduction) and further after 5 months (p < 0.05 each) in contrast (p < 0.05 each) to a control group with state-of-the-art therapy. Similarly, PROM showed a trend towards improvement in dorsal extension of the ankle (p = 0.07). In summary, this is the first report of a novel device with additional benefit to standard therapy for severe PD. These intriguing results warrant the planned prospective randomised controlled trial to prove the concept and mechanism of action of this device.

Keywords: Medical device; Neuromuscular disorder; Physical excersise; Rehabilitation.

Figure 1. Flowchart of the study.

Figure 2. Dynamic standing device Innowalk.

(A) Technical drawing of the Innowalk. (B) The Innowalk with table. (C) Child using the Innowalk in upright position with table. All images retrieved from Made for Movement Group AS; 2018 Copyright by Made for Movement Group AS.

Figure 3. Changes in PROM of the lower extremities with the dynamic standing device.

Changes in PROM of the hip joint. (A) flexion, (B) abduction, (C) adduction, and (D) changes in hip PROM with the Innowalk in comparison to control. Improvement of (E) knee contraction, (F) knee contraction, with the Innowalk in comparison to control, (G) ankle dorsal extension, and (H) ankle dorsal extension with the Innowalk in comparison to control. In (D): p-values above histograms refer to intra-individual comparisons.

Figure 4. Risk of bias assessment.

Quality assessment in this meta-analysis demonstrated a moderate risk of bias in five studies (Käferle, 2014; Hansen, 2014; Tollefsen, 2015; Lauruschkus, Nordmark & Hallstrom, 2017; Thon, 2012) and unclear risk of bias in the remaining four studies (Tornes et al., 2009, 2012; Moen, 2016; Berner & Ahlborg, 2017).