Study of WiiFit to Enhance Walking in Older Adult Amputees

NCT ID: NCT01942798

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2019-05-08

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.

Detailed Description

Lower limb amputation (LLA) is prevalent among older Canadians. Estimates from 2003 suggest that > 2 million individuals were living with LLA in North America with an annual estimated 150,000 incident cases. Over 50% of these procedures are considered major, with 28% of individuals having a transtibial (TT) or below knee amputation and 26% having a transfemoral (TF) or above knee amputation. The WiiNWalk is designed to evaluate whether this intervention does improve the walking capacity of older adults through a series of balancing and other physical activities using the Wii balance board.

An improved walking capacity (ie: being able to walk a longer distance) may effect balance, strength, and fitness components that are critical to improve prosthetic walking. The ability to walk a longer distance may effect a person's lifestyle as it allows the individual to move around his/her environment independently which in turn impacts ones choice of daily and social activities and participation, and therefore providing them with more mobility, freedom and choice.

This study focuses on older adults because, according to Canadian Institute of Health Information data, 50-74 year old were 17 times more likely to have a LLA and individuals aged ≥ 75 were 36 times more likely to have a LLA.The primary reason for this exponential age-related increased incidence is the late stage effects of chronic diseases such as diabetes and vascular disease that are common in older adults.

If as anticipated, the WiiFit proves to increase walking capacity, it will provide a low cost method for those with LLA to have an accessible system that, due to the weight-shifting, balance and aerobic training nature of the Wii games, will serve as a therapeutic agent for rehabilitation.

Conditions

Lower Limb Amputation; Older Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cognitive Games

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.

Group Type: ACTIVE_COMPARATOR

Wii Big Brain Academy Degree program

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Nintendo Wii

Intervention Type: DEVICE

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.

Interventions

Nintendo Wii

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.

Intervention Type: DEVICE

Wii Big Brain Academy Degree program

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

William C. Miller

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William C Miller

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Glenrose Rehabilitation Centre

Edmonton, Alberta, Canada

Holy Family Hospital

Vancouver, British Columbia, Canada

GF Strong Rehabilitation Centre

Vancouver, British Columbia, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

Parkwood Hospital

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 34841917 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25533902 (View on PubMed)

Other Identifiers

H13-01858

Identifier Type: -

Identifier Source: org_study_id