Study of WiiFit to Enhance Walking in Older Adult Amputees

NCT01942798 | Completed

• 1 other identifier: H13-01858
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 5

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.

Conditions

Lower Limb Amputation; Older Adults

Keywords

Rehabilitation; Lower Limb Amputation; Prosthetic; Walking; unilateral transtibial amputation; unilateral transfemoral amputation; older adults; cognitive computer games; home-based training; Nintendo Wii; virtual 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)

Other Outcomes (16)

• Life Space Assessment (LSA)

  Baseline

• StepwatchTM Activity Monitor (SAM)

  Baseline

• Health Utility Index (HUI3)

  Baseline

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 Wii 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

Wii Big Brain Academy Degree program 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.

Cognitive Games

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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

Sponsors & Collaborators

• University of British Columbia: lead

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: 34841917 DERIVED

• 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: 25533902 DERIVED

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)