Abstract
Objectives
Dysfunction of the central nervous system may inflict spastic movement disorder (SMD). Electrical stimuli were identified as promising therapeutic option. Electrical stimulation provided by a 58-electrode full body garment was investigated based on data from regular trial fittings.
Methods
Data from 72 testees were investigated. Age averages 36.6 (19.8) ys with 44 females. The cohort spans infantile cerebral paresis (CP) (n=29), multiple sclerosis (MS) (n=23) and stroke (n=20). Data were stratified by etiology and an entry BBS Score<45.
Results
Effect sizes (Cohen`s d) related BBS, TUG, FGA, 10mWT, WMFT, EQ5D5L and Pain. Significance levels are indicated by *: p<0.05, **: p<0.01, ***: p<0.001, (t): p<0.1: CP: 1.64***, 0.29*, 1.59***, 0.76(t), 1.00***, 0.5*, 1.28***; MS: 1.83***, 0.83***, 1.28**, 1.07***, 0.93*, 1,11**, 0.78*; Stroke: 1.28**, 0.78**, 0.89, 0.92**, 0.71, 1.26*, 0.78*.
Conclusions
Multi-site transcutaneous electrical stimulation may increase ambulation related skills in subjects with SMD stemming from CP, MS and stroke. The results indicate effects on static and dynamic balance, fall risk, mobility, upper extremity improvement and an overall increase in health utility and a reduction in spasticity related pain. Effects are immediate as well as sustained. These results may inspire individual trial fittings and inform further controlled trials.
Acknowledgments
We explicitly acknowledge support by Vittoria Valente.
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Ethical approval: Retrospective data analysis was approved by the ethics board of the University of Göttingen.
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Informed consent: Informed consent was obtained from all individuals included in this investigation.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: AH, SM and AS are full time employees within the Ottobock company group. Ottobock is the owner of Exoneural Network AB. ME and MWe are full time employees of Exoneural Network AB, the manufacturer of the full body garment investigated. WM is contracted for the Medical Advisory Board of Exoneural Network AB. GdC and FB are not reporting a conflict of interest.
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Research funding: None declared.
The data presented specifically in Tables 2a–c and 5 are non-normally distributed. Mean and standard deviation were presented as we chose to lay focus on the characterization of the effects by Cohen’s d. We display the relevant data of the boxplots to allow a higher degree of legibility in Tables A1–A4. Please do also refer to the general description of the table structure at the beginning of the results section.
Median, Range and Quartil data for CP subjects with BBS<45 at T0, T1 and T2.
| Outcome | T0 | T0 | T1 | T1 | T2 | T2 |
|---|---|---|---|---|---|---|
| Median | Quartil 1 | Median | Quartil 1 | Median | Quartil 1 | |
| Range | Quartil 3 | Range | Quartil 3 | Range | Quartil 3 | |
| BBS | 36 | 27.5 | 43 | 33.25 | 43.5 | 38 |
| 4–44 | 38.5 | 5–49 | 46 | 6–54 | 50 | |
| TUG | 15.88 | 12.2 | 14.00 | 11.65 | 13.40 | 11.44 |
| 8–102 | 22.61 | 7.3–82.3 | 21.90 | 8.4–120 | 18.24 | |
| FGA | 10 | 8 | 15 | 10 | 17 | 12 |
| 0–19 | 16 | 1–27 | 23 | 0–27 | 21 | |
| 10mWT | 0.83 | 0.76 | 0.95 | 0.87 | 1.02 | 0.90 |
| 0.27–2.07 | 0.93 | 0.31–1.88 | 1.08 | 0.27–2.14 | 1.30 | |
| WMFT | 50 | 44 | 60 | 48 | 68 | 53 |
| 13–75 | 68 | 15–75 | 71 | 17–75 | 72 | |
| EQ 5D 5L | 0.82 | 0.74 | 0.87 | 0.83 | 0.87 | 0.82 |
| 0.21–1.00 | 0.87 | 0.76–1.0 | 0.91 | 0.72–1 | 0.92 |
Median, Range and Quartil data for MS subjects with BBS<45 at T0, T1 and T2.
| Outcome | T0 | T0 | T1 | T1 | T2 | T1 |
|---|---|---|---|---|---|---|
| Median | Quartil 1 | Median | Quartil 1 | Median | Quartil 1 | |
| Range | Quartil 3 | Range | Quartil 3 | Range | Quartil 3 | |
| BBS | 31 | 19.5 | 40 | 21.5 | 39 | 29 |
| 5–44 | 39.5 | 7–51 | 45 | 10–52 | 48 | |
| TUG | 24.1 | 16.66 | 19.18 | 14.16 | 18.2 | 13.31 |
| 10.2–77.5 | 30.14 | 9.3–66.5 | 26.83 | 8.49–52 | 24.86 | |
| FGA | 11 | 11 | 15.5 | 15 | 19 | 13.5 |
| 8–15 | 11.75 | 11–24 | 18.25 | 9–28 | 22.25 | |
| 10mWT | 0.50 | 0.37 | 0.72 | 0.46 | 0.85 | 0.48 |
| 0.3–1.2 | 0.90 | 0.28–1.2 | 1.03 | 0.37–1.21 | 1.06 | |
| WMFT | 65 | 55.25 | 73 | 70.25 | 74 | 70.75 |
| 50–75 | 74.75 | 64–75 | 75 | 62–75 | 75 | |
| EQ 5D 5L | 0.59 | 0.42 | 0.78 | 0.70 | 0.81 | 0.71 |
| 0.05–0.89 | 0.74 | 0.62–0.94 | 0.81 | 0.24–0.97 | 0.82 | |
| EQ5D 5L PAIN | 2.5 | 2 | 1 | 1 | 1 | 1 |
| 1–5 | 3.75 | 1–3 | 2 | 1–4 | 2.75 |
Median, Range and Quartil data for stroke subjects with BBS<45 at T0, T1 and T2.
| Outcome | T0 | T0 | T1 | T1 | T2 | T2 |
|---|---|---|---|---|---|---|
| Median | Quartil 1 | Median | Quartil 1 | Median | Quartil 1 | |
| Range | Quartil 3 | Range | Quartil 3 | Range | Quartil 3 | |
| BBS | 36.5 | 30.5 | 44 | 38 | 41.5 | 37.75 |
| 20–44 | 42 | 24–48 | 47 | 27–54 | 48.25 | |
| TUG | 23.15 | 17.13 | 16.63 | 13.55 | 16.75 | 12.76 |
| 10.5–2.2 | 45.29 | 8–77.5 | 36.69 | 7.5–63 | 31.56 | |
| FGA | 12.5 | 6.75 | 16.5 | 8.75 | 19.5 | 12.25 |
| 0–28 | 23.5 | 0–30 | 26.5 | 8–28 | 26.75 | |
| 10mWT | 0.52 | 0.32 | 0.72 | 0.35 | 0.81 | 0.54 |
| 0.13–1.11 | 0.78 | 0.13–1.09 | 0.92 | 0.16–1.27 | 0.99 | |
| WMFT | 19 | 13.5 | 23.5 | 14.25 | 40 | 11.25 |
| 3–75 | 39.25 | 3–75 | 44–75 | 3–75 | 59.75 | |
| EQ 5D 5L | 0.62 | 0.38 | 0.74 | 0.69 | 0.82 | 0.76 |
| −0.09-0-8 | 0.78 | 0.21–0.89 | 0.79 | 0.13–0.96 | 0.88 | |
| EQ5D 5L PAIN | 2 | 2 | 1.5 | 1 | 2 | 1 |
| 1–4 | 3.75 | 1–4 | 2 | 1–4 | 2 |
Median, Range and Quartil data for subjects exhibiting pain at T0 at T0, T1 and T2.
| EQ5D 5L PAIN | T0 | T0 | T1 | T1 | T2 | T2 |
|---|---|---|---|---|---|---|
| Median | Quartil 1 | Median | Quartil 1 | Median | Quartil 1 | |
| Range | Quartil 3 | Range | Quartil 3 | Rrange | Quartil 3 | |
| CP | 3 | 2 | 2 | 2 | 2 | 1 |
| 2–4 | 3 | 1–3 | 3 | 1–3 | 2 | |
| MS | 3 | 2 | 2 | 1 | 3 | 1 |
| 2–5 | 4 | 1–4 | 3 | 1–5 | 3.5 | |
| Stroke | 2 | 2 | 2 | 1.5 | 2 | 2 |
| 2–4 | 2.5 | 1–4 | 2.5 | 1–4 | 2 |
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