Using Game-based Exercise to Improve Balance in Cancer Patients

June 24, 2019 updated by: Bijan Najafi, PhD, Baylor College of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • non-technology based exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks, three months, six months
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
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
Time Frame: Baseline and 6 weeks
Measuring fear of falling using Fall Efficacy Scale International (FES-I) questionnaire
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

May 9, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (Estimate)

May 16, 2016

Study Record Updates

Last Update Posted (Actual)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 24, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-38347

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Only de-identified data and associated results will be published in peer-review papers or scientific abstracts.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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