Using Game-based Exercise to Improve Balance in Cancer Patients

NCT ID: NCT02773329

Last Updated: 2019-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-05-31

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.

Detailed Description

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Conditions

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Chemotherapy Induced Peripheral Neuropathy Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention with game-based exercise

Subjects will be receiving sensor-based interactive exercise program (game-based exercise) intervention twice a week for 6 weeks.

Group Type EXPERIMENTAL

sensor-based interactive exercise (game-based exercise)

Intervention Type 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.

Intervention without game-based exercise

Subjects will be receiving non-technology based foot and ankle exercise twice a week for 6 weeks

Group Type ACTIVE_COMPARATOR

Intervention without game-based exercise

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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virtual reality exercise non-technology based exercise

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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Bijan Najafi, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

References

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Schwenk M, Grewal GS, Holloway D, Muchna A, Garland L, Najafi B. Interactive Sensor-Based Balance Training in Older Cancer Patients with Chemotherapy-Induced Peripheral Neuropathy: A Randomized Controlled Trial. Gerontology. 2016;62(5):553-63. doi: 10.1159/000442253. Epub 2015 Dec 18.

Reference Type RESULT
PMID: 26678611 (View on PubMed)

Zahiri M, Chen KM, Zhou H, Nguyen H, Workeneh BT, Yellapragada SV, Sada YH, Schwenk M, Najafi B. Using wearables to screen motor performance deterioration because of cancer and chemotherapy-induced peripheral neuropathy (CIPN) in adults - Toward an early diagnosis of CIPN. J Geriatr Oncol. 2019 Nov;10(6):960-967. doi: 10.1016/j.jgo.2019.01.010. Epub 2019 Jan 18.

Reference Type RESULT
PMID: 30665876 (View on PubMed)

Related Links

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Other Identifiers

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H-38347

Identifier Type: -

Identifier Source: org_study_id

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