Using Game-based Exercise to Improve Balance in Cancer Patients

Study Overview
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Brief Summary
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Cancer patients with chemotherapy-induced peripheral neuropathy (CIPN) have deficits in sensory and motor skills leading to inappropriate proprioceptive feedback, impaired postural control and high fall risk. This study will investigate the acceptability and effect of an interactive motor adaptation balance training program based on wearable sensors for improving balance in older cancer patients with CIPN. Cancer patients with confirmed CIPN will be recruited and will be randomized to either intervention (IG) or control (CG) group and followed for 6 months. The intervention group will take part in a 6-week balance training program twice per week in either their home or in clinic (based on subject preference) under the supervision of a qualified research staff member. This intervention includes interactive game-based balance training including repetitive weight shifting and virtual obstacle crossing tasks. Wearable sensors will provide real-time visual/auditory feedback from foot and ankle position and allowed perception of motor-errors during each motor-action. The control group will be instructed to complete a supervised foot and ankle exercise without using sensor technology. Changes in balance, gait, and physical activity, and number of falls will be compared pre- and post-intervention, as well as 3 and 6 month post intervention. Investigators hypothesize that patients receiving sensor-based exercise training will benefit more compared to group receiving conventional non-technology home-based training in terms of improving functional performance and reducing falls.

Official Title
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Managing Chemotherapy Induced Neuropathy in Cancer Patients Using Game-based Exercise

Conditions
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Chemotherapy Induced Peripheral Neuropathy, Cancer

Intervention / Treatment
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* Other: sensor-based interactive exercise (game-based exercise)
* Other: Intervention without game-based exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer patients Men or women aged 55 years or older Patients undergoing neurotoxic chemotherapy (agents including platinums, vinca alkaloids, taxanes, proteasome inhibitors and interferons) Confirmed peripheral neuropathy (VPT>25) will be eligible to participate Exclusion Criteria: Subjects will be excluded if they have undergone surgery in the last 6-8 weeks Have Parkinson's Disease Stroke patients Dementia patients Have an active foot ulcer Have an active infection Lower extremity major amputation Patient is taking medications unrelated to cancer treatment that may affect balance and gait Patient has other medical conditions that may affect their balance and gait Patient is unable to ambulate without assistance.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention with game-based exercise<br>Subjects will be receiving sensor-based interactive exercise program (game-based exercise) intervention twice a week for 6 weeks. | Other: sensor-based interactive exercise (game-based exercise)<br>* This intervention includes interactive game-based balance training including repetitive weight shifting and virtual obstacle crossing tasks. Wearable sensors will provide real-time visual/auditory feedback from foot and ankle position and allowed perception of motor-errors during each motor-action.<br>* Other names: virtual reality exercise;|
| Active Comparator: Intervention without game-based exercise<br>Subjects will be receiving non-technology based foot and ankle exercise twice a week for 6 weeks | Other: Intervention without game-based exercise<br>* Subjects are asked to perform non-technology based foot and ankle exercises, which include body weight shifting and obstacle crossing tasks.<br>* Other names: non-technology based exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Speed change from Baseline to 6 weeks, three months and six months | walking ability is quantified by gait speed. | Baseline, 6 weeks, three months, six months | 
| Balance change from Baseline to 6 weeks, three months and six months | balance is quantified by body sway | Baseline, 6 weeks, three months, six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of falling change from Baseline to 6 weeks | Measuring fear of falling using Fall Efficacy Scale International (FES-I) questionnaire | Baseline and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy induced peripheral neuropathy, Cancer, game-based exercise, exercise, wearable sensors, balance, falls, virtual reality