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Completed

NCT Number: NCT02773329

Using Game-based Exercise to Improve Balance in Cancer Patients

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.

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Key information

Conditions

Chemotherapy Induced Peripheral Neuropathy Behavior Cancer Motor Activity Neoplasms

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sensor-based interactive exercise (game-based exercise)

Other

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.

Other names: virtual reality exercise

Intervention without game-based exercise

Other

Subjects are asked to perform non-technology based foot and ankle exercises, which include body weight shifting and obstacle crossing tasks.

Other names: non-technology based exercise

Primary outcomes

  1. Gait Speed change from Baseline to 6 weeks, three months and six months

    Time frame: Baseline, 6 weeks, three months, six months

    walking ability is quantified by gait speed.

  2. Balance change from Baseline to 6 weeks, three months and six months

    Time frame: Baseline, 6 weeks, three months, six months

    balance is quantified by body sway

Secondary outcomes

  1. Fear of falling change from Baseline to 6 weeks

    Time frame: Baseline and 6 weeks

    Measuring fear of falling using Fall Efficacy Scale International (FES-I) questionnaire

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 16, 2016
Registry last updated
Jun 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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