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Using Game-based Exercise to Improve Balance in Cancer Patients

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ClinicalTrials.gov Identifier: NCT02773329
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : June 26, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Bijan Najafi, PhD, Baylor College of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chemotherapy Induced Peripheral Neuropathy Cancer Other: sensor-based interactive exercise (game-based exercise) Other: Intervention without game-based exercise Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Managing Chemotherapy Induced Neuropathy in Cancer Patients Using Game-based Exercise
Actual Study Start Date : May 2016
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention with game-based exercise
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)
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 Name: virtual reality exercise

Active Comparator: Intervention without game-based exercise
Subjects will be receiving non-technology based foot and ankle exercise twice a week for 6 weeks
Other: Intervention without game-based exercise
Subjects are asked to perform non-technology based foot and ankle exercises, which include body weight shifting and obstacle crossing tasks.
Other Name: non-technology based exercise




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773329


Locations
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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
National Institutes of Health (NIH)
Additional Information:
Publications of Results:
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Responsible Party: Bijan Najafi, PhD, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02773329    
Other Study ID Numbers: H-38347
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Only de-identified data and associated results will be published in peer-review papers or scientific abstracts.
Keywords provided by Bijan Najafi, PhD, Baylor College of Medicine:
chemotherapy induced peripheral neuropathy
Cancer
game-based exercise
exercise
wearable sensors
balance
falls
virtual reality
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases