NCT01942798

Brief Summary

WiiNWALK is a 4 week physical activity, with the intervention of a WiiFit, targeted to improve walking capacity in individuals with either a unilateral below-knee or above-knee amputation. This is a randomized control trial to evaluate the effectiveness of the WiiNWALK program in older (50+ years) community living adults with lower limb amputations (LLA). Hypothesis: We expect the WiiNWALK intervention will have a treatment effect with improvement in functional walking capacity, compared to the control group who will only be playing cognitive games. Secondarily, a functional walking capacity will also include an improvement in lower extremity strength and balance, inter-limb gait symmetry, balance confidence along with participation in daily and social activities, locomotor capabilities and an increase in physical activities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2019

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

5.1 years

First QC Date

August 27, 2013

Last Update Submit

July 19, 2024

Conditions

Lower Limb AmputationOlder Adults

Keywords

RehabilitationLower Limb AmputationProstheticWalkingunilateral transtibial amputationunilateral transfemoral amputationolder adultscognitive computer gameshome-based trainingNintendo Wiivirtual reality

Outcome Measures

Primary Outcomes (3)

  • 2 Minute Walk to assess walking speed and endurance improvement

    Starting from a standing position, subjects are asked to walk as far as they can in a safe manner for two minutes over a flat out and back 80-metre course. The distance travelled to the nearest metre is recorded.

    Baseline, Post Intervention (1 month after baseline), 3 week Follow-Up

  • Change in Two Minute Walk Test from baseline

    To assess changes in the participant's walking speed and endurance, they will start from a standing position, subjects are asked to walk as far as they can in a safe manner for two minutes over a flat out and back 80-metre course. The distance traveled to the nearest meter is recorded.

    Post-Intervention (1 month from Baseline)

  • Change in two minute walk test from 1 month assessment

    Starting from a standing position, subjects are asked to walk as far as they can in a safe manner for two minutes over a flat out and back 80-metre course. The distance travelled to the nearest metre is recorded.

    Follow-Up (3 weeks from post-intervention)

Secondary Outcomes (7)

  • Physical Activity Scale for the Elderly (PASE)

    Baseline, Post Intervention (1 month after baseline), 3 week Follow-Up

  • Short Physical Performance Battery (SPPB) ability

    Baseline

  • Change in Physical Activity Scale of the Elderly (PASE)

    Post-Intervention (1 month from baseline)

  • Change in Physical Activity Scale for the Elderly (PASE)

    Follow-Up (3 weeks from post-intervention)

  • Change in Short Physical Performance Battery (SPPB)

    Post Intervention (1 month from baseline)

  • +2 more secondary outcomes

Other Outcomes (16)

  • Life Space Assessment (LSA)

    Baseline

  • StepwatchTM Activity Monitor (SAM)

    Baseline

  • Health Utility Index (HUI3)

    Baseline

  • +13 more other outcomes

Study Arms (2)

Cognitive Games

ACTIVE COMPARATOR

The Cognitive Games group will receive 40 minute supervised group training three times per week for a period of four weeks. The group for the first week will be held at the clinic, while the remaining three weeks be conducted at the subject's home and supervised by the Trainer remotely using a tablet with video conferencing capability. At the end of the four-week Supervised Phase, subjects will retain the Wii units and they will be encouraged to use the program on their own for an additional period of four weeks (Unsupervised Phase). Subjects in the control group will play cognitive oriented video games using Wii Big Brain Academy Degree program. BigBrain™ is a video gaming system which has games and exercises to improve cognitive function(identify, memorize, analyze, compute, and visualize). Subjects use the Wii handheld remote to participate in the games by pointing and clicking the remote to select on-screen answers in response to on-screen questions.

Device: Wii Big Brain Academy Degree program

WiiNWALK Intervention

EXPERIMENTAL

The intervention group will also receive 40 minute supervised group training three times per week for a period of four weeks. Interventions conducted over the first week will be held at the clinic, while the remaining three weeks be conducted at the subject's home and supervised by the Trainer remotely. At the end of the four-week Supervised Phase, subjects will retain the Wii units and they will be encouraged to use the program on their own for an additional period of four weeks (Unsupervised Phase). The WiiNWALK protocol consists of performing Nintendo WiiFit activities. Subjects stand on the WiiFit balance board and interact with the WiiFit games through weight shifting or by using the Wii handheld remote control. The intervention protocol will include selected exercises consisting of: 1) Yoga 2) Balance Tasks 3) Strength training and 4) Aerobics. At the in-clinic sessions in Vancouver, a motion-sensing device will also record video and skeleton data of the participant.

Device: Nintendo Wii

Interventions

Nintendo WiiDEVICE

Subjects will receive the intervention for 40-minute sessions, 3x/week for 4 weeks. The interventions will be administered in combination of onsite group training and individualized home-based training.

WiiNWALK Intervention
Wii Big Brain Academy Degree programDEVICE

Subjects will receive the intervention for 40-minute sessions, 3x/week for 4 weeks. The interventions will be administered in combination of onsite group training and individualized home-based training.

Cognitive Games

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects will be at least 50 years of age and have a unilateral TT or TF amputation
  • Use their prosthesis for at least two hours per day for the past 6 months
  • Be cognitively able to engage in the program
  • Have a television that will enable connection to Nintendo hardware

You may not qualify if:

  • Are unable to communicate in English
  • Cannot provide informed consent
  • Have important medical conditions
  • Have prosthetic fit issues (ie: pain and discomfort)
  • Are currently enrolled in another formal exercise or training program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Glenrose Rehabilitation Centre

Edmonton, Alberta, T5G 0B7, Canada

Location

Holy Family Hospital

Vancouver, British Columbia, V5P 3L6, Canada

Location

GF Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Parkwood Hospital

London, Ontario, N6C 5J1, Canada

Location

Related Publications (2)

  • Tao G, Miller WC, Eng JJ, Esfandiari E, Imam B, Lindstrom H, Payne MW. Group-based telerehabilitation intervention using Wii Fit to improve walking in older adults with lower limb amputation (WiiNWalk): A randomized control trial. Clin Rehabil. 2022 Mar;36(3):331-341. doi: 10.1177/02692155211061222. Epub 2021 Nov 29.

    PMID: 34841917DERIVED

  • Imam B, Miller WC, Finlayson HC, Eng JJ, Payne MW, Jarus T, Goldsmith CH, Mitchell IM. A Telehealth Intervention Using Nintendo Wii Fit Balance Boards and iPads to Improve Walking in Older Adults With Lower Limb Amputation (Wii.n.Walk): Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2014 Dec 22;3(4):e80. doi: 10.2196/resprot.4031.

    PMID: 25533902DERIVED

Study Officials

  • William C Miller

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 27, 2013

First Posted

September 16, 2013

Study Start

April 1, 2014

Primary Completion

May 8, 2019

Study Completion

May 8, 2019

Last Updated

July 23, 2024

Record last verified: 2024-07

Locations

CA(5)