NCT01715662

Brief Summary

This is a pilot randomized controlled trial to assess the feasibility of a home-based Nintendo Wii Fit program (Wii.n.Walk) to improve walking capacity in older adults with a lower limb amputation. Twenty four individuals with a unilateral below-knee or above-knee amputation will be randomly allocated to Wii.n.Walk or control arm. The Wii.n.Walk arm will receive aerobics, weight-shifting, balance games and exercises using the Wii Fit gaming technology. The control arm will receive cognitive computer games and exercises using Wii Big Brain Academy Degree program. Both groups will receive the intervention for 40-minute sessions, 3x/week for 4 weeks. The interventions will be conducted in combinations of in-clinic group (n=3) training and individualized in-home training. Outcome measurements will be completed by a blinded evaluator at baseline, end of treatment, and 3 weeks after the end of treatment. Hypothesis: Our primary hypothesis is that Wii.n.Walk is feasible. Our primary clinical hypothesis is that participants in the Wii.n.Walk intervention group will experience an improvement in walking capacity compared to the control group. The secondary clinical hypothesis is that participants in the Wii.n.Walk group will experience an improvement in balance confidence, physical activity, number of steps taken per day, walking while talking, lower limb functioning, and locomotor capabilities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 29, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

1.1 years

First QC Date

October 15, 2012

Last Update Submit

May 25, 2018

Conditions

Lower Limb Amputation

Keywords

rehabilitationlower limb amputationunilateral transtibial amputationunilateral transfemoral amputationolder adultscognitive computer gameshome-based trainingNintendo Wiivirtual reality

Outcome Measures

Primary Outcomes (1)

  • Change in Two Minute Walk Test

    The Two Minute Walk Test (2MWT) will be used to measure walking capacity. Starting from a standing position, participants will be asked to walk as far as they can in a safe manner for two minutes over an indoor 80-meter flat out course.

    Baseline, end of treatment, 3 weeks post treatment

Secondary Outcomes (6)

  • Short Physical Performance Battery (SPPB)

    Baseline, end of treatment, 3 weeks post treatment

  • The Physical Activity Scale for the Elderly (PASE)

    Baseline, end of treatment, 3 weeks post treatment

  • Walking While Talking Test

    Baseline, end of treatment, 3 weeks post treatment

  • Activities-specific Balance Confidence scale (ABC)

    Baseline, end of treatment, 3 weeks post treatment

  • Modus Health StepwatchTM Activity Monitor (SAM)

    Baseline, end of treatment, 3 weeks post treatment

  • +1 more secondary outcomes

Other Outcomes (1)

  • Feasibility indicators

    Throughout and at the end of study

Study Arms (2)

Wii.n.Walk

EXPERIMENTAL

Subjects (n=12) in the experimental arm (Wii.n.Walk) will be trained using the Wii Fit for 40-minute sessions, 3 times a week for a period of 4 weeks. Subjects will stand on the Wii Fit balance board and interact with the games through weight shifting or using the Wii remote controller. The intervention protocol includes: 1) Yoga (static single and double leg exercises), 2) Balance games (lateral and poster/anterior weight shifting exercises in standing), 3) Aerobics (running on spot and step class), and 4) Strength training (dynamic single and double leg exercises). The sessions will start in the clinic with a group of 3 participants and will graduate to individualized in-home training starting from week 2. For the in-clinic training sessions, a trained research assistant will administer the intervention and will provide external cueing and correction of the pose if the participants use unsafe technique.

Device: Wii.n.Walk

Control

PLACEBO COMPARATOR

Subjects (n=12) in the control arm will play cognitive computer games using Wii Big Brain for the same frequency and duration as the Wii.n.Walk arm. The sessions will start in the clinic with a group of 3 participants and will graduate to individualized in-home training starting from week 2. For the in-clinic sessions, a research assistant will administer the intervention and will provide supervision. Wii Big Brain is a low-cost commercially available gaming software to improve cognitive function.

Device: Wii Big Brain

Interventions

Wii.n.WalkDEVICE

Subjects will be trained using Nintendo Wii Fit (commercial fitness gaming software) for 40-minute sessions, 3x/week for 4 weeks. The intervention will initially be conducted in the clinic with a group of 3 participants and will graduate to in-home sessions starting from week 2.

Wii.n.Walk
Wii Big BrainDEVICE

Subjects in the control group will be trained using Wii Big Brain Academy Degree program which is a low-cost commercially available gaming software to improve cognitive function. The intervention will initially be conducted in the clinic with a group of 3 participants and will graduate to in-home sessions starting from week 2.

Control

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 1 year post a unilateral transtibial or transfemoral amputation
  • years of age or older
  • have been using a prosthesis for at least 2 hours per day for the past 6 months
  • currently not participating in another formal exercise or training program.

You may not qualify if:

  • not able to provide an informed consent form
  • not able to communicate in English
  • has significant medical conditions (e.g. congestive heart failure) that contraindicates participation in exercise program
  • had prosthetic socket fit issues (scores \<6 on the Prosthetic Socket Fit Comfort Scale).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Holy Family Hospital

Vancouver, British Columbia, V5P 3L6, Canada

Location

GF Strong

Vancouver, British Columbia, V5Z 2G9, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Study Officials

  • William C. Miller, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2012

First Posted

October 29, 2012

Study Start

January 1, 2013

Primary Completion

February 1, 2014

Study Completion

August 1, 2015

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

CA(3)