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Using Game-based Exercise to Improve Balance in Cancer Patients

Baylor College of Medicine logo

Baylor College of Medicine

Status and phase

Completed
Phase 2

Conditions

Chemotherapy Induced Peripheral Neuropathy
Cancer

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02773329
H-38347

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

35 participants in 2 patient groups

Intervention with game-based exercise
Experimental group
Description:
Subjects will be receiving sensor-based interactive exercise program (game-based exercise) intervention twice a week for 6 weeks.
Treatment:
Other: sensor-based interactive exercise (game-based exercise)
Intervention without game-based exercise
Active Comparator group
Description:
Subjects will be receiving non-technology based foot and ankle exercise twice a week for 6 weeks
Treatment:
Other: Intervention without game-based exercise

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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