Arm and Leg Cycling Exercise After Stroke

Stroke Clinical Trial

Official title:

Adjunct Locomotor Training to Improve Walking Ability After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02232867
• Other study ID #: 07-480-04d
• Status: Recruiting
• Phase: N/A
• First received: August 28, 2014
• Last updated: September 2, 2014
• Start date: July 2011
• Est. completion date: March 2015

Study information

• Verified date: September 2014
• Source: University of Victoria
• Contact: Taryn Klarner, M.Sc.
• Phone: (250) 472-5487
• Email: rnl[@]uvic.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

It has been found that arm and leg cycling is similar to walking in terms of the muscle activation patterns and joint ranges of motion. In addition, arm and leg cycling and walking activate similar neural pathways. Another advantage of arm and leg cycling is that it involves coordination of all four limbs in a rhythmic movement. This may be particularly beneficial given previous findings that arm movement contributes to the activation of leg muscles during walking in humans. This is achieved with interconnected neural pathways that link the arms to the legs. These neural interlimb connections remain intact in stroke victims, such that maximizing the contribution of the arms to the legs may increase coordination for walking. Thus, the objectives of this research are to determine if arm and leg cycling can be used to increase the strength of interlimb connections and if this helps to improve walking ability in a post-stroke population. It is hypothesized that arm and leg cycling will transfer to improvements in walking in a post stroke population.

Description:

For those who have suffered a stroke, damage to the brain can result in a decreased ability to walk, thus decreasing quality of life in a significant way. Traditionally, body weight supported treadmill training has been used for walking rehabilitation; however, this therapy requires specialized technicians, equipment, and facilities. Arm and leg cycle ergometers, a device commonly found in a gym, could provide an inexpensive and readily accessible means for walking rehabilitation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• stroke

• lives within the Victoria, Vancouver Island, and Vancouver mainland communities

Exclusion Criteria:

• inability to stand for 5 minutes unassisted

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Arm and Leg Cycling Exercise Program
Participants will perform arm and leg cycling training three times a week, with 30 minutes of aggregate exercise time per session. To evaluate the physiological cost of exercise, heart rate and a rating of perceived exertion will be collected. The progressive element of this training will include increasing the resistance of the ergometer over the six weeks in order to maintain the same relative exercise stress.

Locations

Country	Name	City	State
Canada	Rehabilitation Neuroscience Laboratory	Victoria	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of Victoria	Canadian Stroke Network, Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Treadmill Walking Characteristics	Treadmill walking characteristics will be gauged via a customized analysis of muscle activity patterns and lower limb joint kinematics. Walking frequency, symmetry, and timing will also be analyzed	Baseline, immediately post-intervention (average of 4 days following last exercise session)	No
Secondary	Interlimb Connections	To assess the strength of inter-limb coupling, simultaneous electrical stimulation will be applied to (5x1.0ms trains at 300Hz) the cutaneous nerves in the hand (superficial radial) and foot (superficial peroneal). The reflex responses recorded in all four limbs will be evaluated at different phases of the walking cycle.	Baseline, immediately post-intervention (average of 4 days following the last exercise session)	No
Secondary	Fugl-Meyer Assessment	The Fugl-Meyer Assessment is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.	Baseline, immediately post-intervention (average of 4 days following the last exercise session)	No
Secondary	Brunnstrom recovery stages	The Brunnstrom Approach emphasises the synergic pattern of movement which develops during recovery from hemiplegia.	Baseline, immediately post-intervention (average of 4 days following the last exercise session)	No
Secondary	Timed up and go test	The Timed Up and Go test is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require.	Baseline, immediately post-intervention (average of 4 days following the last exercise session)	No
Secondary	10 meter walk test	The 10 meter walk test is a timed test to evaluate walking speed	Baseline, immediately post-intervention (average of 4 days following the last exercise session)	No
Secondary	Six minute walk test	The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.	Baseline, immediately post-intervention (average of 4 days following last exercise session)	No