Nintendo Wii Fit as an adjunct to physiotherapy following lower limb fractures: preliminary feasibility, safety and sample size considerations

Nintendo Wii Fit as an adjunct to physiotherapy following lower limb fractures: preliminary feasibility, safety and sample size considerations

Accepted Manuscript Title: Nintendo Wii Fit as an adjunct to physiotherapy following lower limb fractures: preliminary feasibility, safety and sample ...

72KB Sizes 5 Downloads 32 Views

Accepted Manuscript Title: Nintendo Wii Fit as an adjunct to physiotherapy following lower limb fractures: preliminary feasibility, safety and sample size considerations Author: S.M. McPhail M. O’Hara E. Gane P. Tonks J. Bullock-Saxton S.S. Kuys PII: DOI: Reference:

S0031-9406(15)03787-6 http://dx.doi.org/doi:10.1016/j.physio.2015.04.006 PHYST 837

To appear in:

Physiotherapy

Received date: Accepted date:

1-8-2014 5-4-2015

Please cite this article as: McPhail SM, O’Hara M, Gane E, Tonks P, Bullock-Saxton J, Kuys SS, Nintendo Wii Fit as an adjunct to physiotherapy following lower limb fractures: preliminary feasibility, safety and sample size considerations, Physiotherapy (2015), http://dx.doi.org/10.1016/j.physio.2015.04.006 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

1

Nintendo Wii Fit as an adjunct to physiotherapy following

2

lower limb fractures: preliminary feasibility, safety and

3

sample size considerations

ip t

1

4

6

Kuysf,g

M. O’Harac, E. Ganea,d, P. Tonksc, J. Bullock-Saxtone, S.S.

cr

S.M. McPhaila,b,*,

us

5

7 8

a

9

Queensland, Australia

an

Centre for Functioning and Health Research, Metro South Health, Brisbane,

10

b

11

Work, Queensland University of Technology, Brisbane, Queensland, Australia

12

c

13

Australia

14

d

15

Queensland, Australia

16

e

17

f

18

g

M

Institute of Health and Biomedical Innovation and School of Public Health and Social

te

d

The Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland,

Ac ce p

School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane,

Faculty of Health, Australian Catholic University, Brisbane, Queensland, Australia

Griffith Health Institute, Griffith University, Gold Coast, Queensland, Australia

19

The Prince Charles Hospital, Metro North Health, Brisbane, Queensland, Australia

20 21 22

*

23

QLD 4102, Australia. Tel.: +61 7 3406 2266; fax: +61 7 3406 2267.

24

E-mail address: [email protected] (S. McPhail).

Corresponding author. Address: Centre for Functioning and Health Research, PO Box 6053, Buranda,

Page 1 of 8

4

Abstract Objective The Nintendo Wii Fit integrates virtual gaming with body movement, and may be suitable as an adjunct to conventional physiotherapy following lower limb

ip t

fractures. This study examined the feasibly and safety of using the Wii Fit as an adjunct

considerations for an appropriately powered randomised trial.

cr

to outpatient physiotherapy following lower limb fractures, and reports sample size

us

Methodology Ambulatory patients receiving physiotherapy following a lower limb fracture participated in this study (n=18). All participants received usual care

an

(individual physiotherapy). The first nine participants also used the Wii Fit under the supervision of their treating clinician as an adjunct to usual care. Adverse events,

M

fracture malunion or exacerbation of symptoms were recorded. Pain, balance and patient-reported function were assessed at baseline and discharge from physiotherapy.

d

Results No adverse events were attributed to either the usual care physiotherapy or Wii

te

Fit intervention for any patient. Overall, 15 (83%) participants completed both

Ac ce p

assessments and interventions as scheduled. For 80% power in a clinical trial, the number of complete datasets required in each group to detect a small, medium or large effect of the Wii Fit at a post-intervention assessment was calculated at 175, 63 and 25, respectively.

Conclusions The Nintendo Wii Fit was safe and feasible as an adjunct to ambulatory physiotherapy in this sample. When considering a likely small effect size and the 17% dropout rate observed in this study, 211 participants would be required in each clinical trial group. A larger effect size or multiple repeated measures design would require fewer participants. Keywords: Fracture; Nintendo Wii; Physiotherapy; Rehabilitation; Safety; Game

Page 2 of 8

5

Introduction Re-establishing normal gait, balance and weight bearing through the lower limbs is a high priority once fractures of the lower limb have been stabilised. Therapeutic options

ip t

for weight shift and balance training have recently been expanded with the growth in

popularity of virtual gaming systems [1–4]. One such device that integrates virtual

cr

gaming with body movement is the Nintendo Wii, a popular gaming console that allows

us

the player to interact with the game via three-dimensional movements [1,5]. This study examined the feasibility and safety of using the Wii Fit as an adjunct to outpatient

an

physiotherapy following lower limb fractures, and reports sample size considerations

M

for an appropriately powered randomised trial.

Design and participants

d

Methods

te

A clinical (non-randomised) investigation was undertaken at a tertiary hospital. Patients

Ac ce p

receiving outpatient physiotherapy following a lower limb fracture participated in the study (n=18). All participants received usual care (individual physiotherapy). The first nine participants also used the Wii Fit at the clinic as an adjunct to usual care.

Interventions

Usual care typically included manual therapies and progressive exercises to improve joint range and muscle strength, reduce pain, promote normal gait, and address any other functional deficits related to the injury. The Wii Fit intervention involved using the Wii Fit gaming console for 20 minutes during six clinic sessions as an adjunct to usual care. Patients were instructed to select games from the commercial ‘Wii Fit Plus’

Page 3 of 8

6

suite, which challenged standing balance and weight shifting between the affected and unaffected lower limbs. This required participants to stand barefoot on a Wii balance board (force platform) 2 m from a 102-cm plasma television screen. To influence the

ip t

game outcome, participants were required to shift their centre of gravity in a

mediolateral direction, or combined anteroposterior and mediolateral directions. Success

cr

led to an increase in difficulty associated with game progression. During this

us

investigation, participants were able to self-govern their weight-shifting intensity.

an

Outcomes

The primary outcome was adverse events potentially attributable to the Wii Fit or

M

conventional physiotherapy. Other outcomes included feasibility (number of patients who successfully completed all Wii Fit intervention sessions), a 100-mm pain visual

d

analogue scale (VAS), self-reported function [Lower Extremity Functional Scale

te

(LEFS)] [6], single leg stance (SLS) time with eyes closed [7] (maximum 30 seconds),

Ac ce p

step test [8], functional reach test [9] and gait parameters measured using the GaitRITE [10] electronic walkway (CIR Systems Inc., Sparta, NJ, USA) when instructed to walk at a ‘comfortable pace’ and a ‘fast pace’. Any reason for ceasing participation was recorded.

Analysis

Conventional descriptive statistics were used to summarise outcome measures at each assessment. To illustrate sample size considerations for a definitive randomised trial, sample size calculations were prepared for possible small, medium or large effect sizes

Page 4 of 8

7

(as defined by Cohen’s d of 0.3, 0.5 and 0.8, respectively) for a between-group comparison at a post-intervention assessment (assuming alpha=0.05).

ip t

Results

Overall, 15 (83%) participants completed both assessments and interventions as

cr

scheduled. Demographic, clinical and self-reported outcomes for these participants are

us

presented in Table 1. One Wii group participant (malunion) and two usual care group participants (infection, malunion) did not complete their respective interventions as

an

scheduled after being referred back to their treating orthopaedic teams. There were no

M

adverse effects attributed to the usual care or Wii Fit interventions.

d



te

For a definitive clinical trial, the number of complete datasets required in each

Ac ce p

group to detect a small, medium or large effect of the Wii Fit as an adjunct to usual care was calculated at 175, 63 and 25, respectively, for 80% power or 234, 50 and 33, respectively, for 90% power.

Discussion

To the authors’ knowledge, this is the first study to report findings to support the safety and feasibility of the Nintendo Wii Fit as an adjunct to conventional physiotherapy following lower limb fractures. This finding is consistent with investigations among clinical groups with different risk profiles and clinical considerations, where evidence of safety and feasibility has been reported [1–4]. The preliminary descriptive data across a

Page 5 of 8

8

range of clinical outcomes were not compelling for potential efficacy beyond usual care alone at the dosage and intensity employed in this study. It is likely that more sessions, longer session duration and potentially higher intensity activity within the session are

ip t

required to demonstrate potential clinical efficacy of the Wii Fit intervention. When

considering a conservative effect size in comparison to usual care and the 17% dropout

cr

observed in this study, an estimate of 211 participants would be required in each group

us

to detect a small between-group difference at a post-intervention assessment point. It is noteworthy that this is a conservative estimate, and multiple repeated measures or a

an

larger effect size would reduce the sample size requirement.

M

Acknowledgements

The authors would like to acknowledge valuable contributions of staff and students at

te

d

the participating site when planning and undertaking this investigation.

Ac ce p

Ethical approval: This investigation was approved by the Metro South Human Research Ethics Committee. Patients provided written informed consent prior to participation.

Funding: SMM is supported by a National Health and Medical Research Council (of Australia) fellowship in the field of Clinical Research.

Conflict of interest: None declared.

References

Page 6 of 8

9

[1] Agmon M, Perry CK, Phelan E, Demiris G, Nguyen HQ. A pilot study of Wii Fit exergames to improve balance in older adults. J Geriatr Phys Ther 2011;34:161–7. [2] Barry G, Galna B, Rochester L. The role of exergaming in Parkinson's disease

ip t

rehabilitation: a systematic review of the evidence. J Neuroeng Rehabil 2014;11:33.

[3] Bateni H. Changes in balance in older adults based on use of physical therapy vs the

cr

Wii Fit gaming system: a preliminary study. Physiotherapy 2012;98:211–6.

us

[4] Bieryla KA, Dold NM. Feasibility of Wii Fit training to improve clinical measures of balance in older adults. Clin Intervent Aging 2013;8:775–81.

an

[5] Bower KJ, Clark RA, McGinley JL, Martin CL, Miller KJ. Clinical feasibility of the Nintendo Wii for balance training post-stroke: a phase II randomized controlled trial in

M

an inpatient setting. Clin Rehabil 2014;28:912–23.

[6] Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional

American

Orthopaedic

Research

Network.

Phys

Ther

Ac ce p

1999;79:371–83.

Rehabilitation

te

North

d

Scale (LEFS): scale development, measurement properties, and clinical application.

[7] Hertel J, Gay MR, Denegar CR. Differences in postural control during single-leg stance among healthy individuals with different foot types. J Athl Train 2002;37:129. [8] Hill KD. A new test of dynamic standing balance for stroke patients: reliability, validity and comparison with healthy elderly. Physiother Can 1996;48:257–62. [9] Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol 1990;45:M192–7. [10] Bilney B, Morris M, Webster K. Concurrent related validity of the GAITRite® walkway system for quantification of the spatial and temporal parameters of gait. Gait Posture 2003;17:68–74.

Page 7 of 8

11

Table 1 Clinical and demographic variables, and median [interquartile range (IQR)] clinical test results for the usual care and Wii Fit intervention groups at baseline and completion of ambulatory physiotherapy

Fast gait

33 34 35

ip t

Wii Fit intervention Baseline Completion 37 (23 to 52) 4 (50) -

cr

2 (29) 3 (43) 1 (14) 1 (14)

2 (25) 6 (75) 0 0

-

-

5 (62) 3 (38)

-

15 (3 to 30)

2 (25) 6 (75) 2 (1 to 7)

7 (2 to 30)

9 (4 to 26)

16 (11 to 30)

13 (6 to 23)

19 (5 to 30)

13 (9 to 15) 12 (11 to 14) 36 (32 to 44) 8 (3 to 21) 40 (22 to 46) 79 (49 to 94) 15 (12 to 19) 1.5 (1.2 to 1.7) 44 (40 to 57) 50 (37 to 57) 63 (62 to 66) 63 (63 to 70) 129 (78 to 157) 12 (8 to 16) 1.9 (1.5 to 2.1) 55 (47 to 77) 60 (45 to 80) 61 (60 to 66) 60 (56 to 62)

18 (16 to 19) 18 (17 to 21) 43 (41 to 44) 0 (0 to 11) 48 (44 to 70) 121 (119 to 142) 10 (9 to 11) 1.9 (1.7 to 2.0) 68 (60 to 72) 67 (63 to 72) 61 (60 to 63) 61 (59 to 62) 188 (171 to 219) 8 (7 to 10) 2.4 (2.1 to 2.5) 76 (67 to 90) 77 (70 to 92) 58 (58 to 60) 58 (57 to 59)

16 (13 to 16) 15 (11 to 17) 39 (35 to 42) 17 (4 to 19) 43 (35 to 46) 94 (83 to 100) 12 (11 to 12) 1.7 (1.4 to 1.8) 58 (54 to 59) 60 (53 to 64) 62 (60 to 64) 63 (62 to 65) 126 (118 to 152) 10 (9 to 10) 2.0 (1.6 to 2.1) 71 (63 to 74) 67 (65 to 74) 59 (56 to 61) 61 (60 to 62)

16 (13 to 19) 17 (13 to 19) 40 (37 to 46) 3 (0 to 6) 51 (46 to 56) 114 (104 to 126) 11 (10 to 11) 1.8 (1.7 to 2) 61 (57 to 67) 63 (59 to 69) 60 (59 to 62) 61 (61 to 63) 157 (130 to 202) 9 (8 to 11) 2.2 (2.0 to 2.3) 74 (62 to 88) 80 (65 to 86) 57 (56 to 59) 60 (59 to 61)

d

M

1 (14) 6 (86) 1 (1 to 12)

-

us

5 (71) 2 (29)

te

Age in years, median (IQR) Females, n (%) Fracture site, n (%) Knee Ankle/foot Hip Hip and knee Mechanism of injury, n (%) Fall Other trauma Fracture stabilisation, n (%) Conservative (non-surgical) Surgical SLSa eyes closed injured (seconds) SLS eyes closed non-injured (seconds) Step test injured (steps) Step test non injured (steps) Functional reach (cm) Pain VAS (mm)b LEFS (score/80)c Velocity (cm/second) Step count (steps) Cadence (steps/second) Step length injured (cm) Step length non injured (cm) Stance percentage injured (%) Stance percentage non injured (%) Velocity (cm/second) Step count (steps) Cadence (step/second) Step length injured (cm) Step length non injured (cm) Stance percentage injured (%) Stance percentage non injured (%)

Usual care Baseline Completion 43 (30 to 53) 4 (57) -

Ac ce p

Comfortable gait

Variable

an

27 28 29 30 31 32

SLS, single leg stance (to a maximum of 30 seconds); VAS, visual analogue scale (100 mm); LEFS, lower extremity functional score.

Page 8 of 8