Clinical trial NCT02270398: Dual-task Training in Chronic Stroke
Official title: Training Dual-task Balance and Walking in Community-dwelling Older Adults With Chronic Stroke: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Exercise
Balance
Gait
Community
Rehabilitation
Dual-task
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: West China Hospital
First posted: 2014-10-21
Enrollment: 84
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background Functional community ambulation not only requires a critical level of postural control and walking skills, but also the ability to engage in cognitive tasks while walking (i.e., dual-task walking) and adapt to the constantly-changing environmental contexts. There is evidence showed that dual-task balance and gait performance is significantly impaired after stroke. Increasing evidence also suggests that dual-task balance and gait performance is useful for predicting falls among individuals with stroke. Considering the high clinical relevance of dual-task balance and gait performance, it is essential that stroke rehabilitation adequately addresses dual-task deficits. Developing specific dual-task balance and gait training to enhance dual-task performance is thus necessary to promote community ambulation and reintegration.

Study Aim The aim of this Introduction Many individuals after stroke continue to cope with residual physical impairments after discharge from hospital. One of the major problems encountered by people after stroke is community reintegration. Functional community ambulation not only requires a critical level of postural control and walking skills, but also the ability to engage in cognitive tasks while walking (i.e., dual-task walking) and adapt to the constantly-changing environmental contexts. There has been an increasing awareness of the importance of dual-task gait performance in community-dwelling individuals with stroke in the past few years.

There is evidence showed that dual-task balance and gait performance is significantly impaired after stroke. Increasing evidence also suggests that dual-task balance and gait performance is useful for predicting falls among individuals with stroke. Considering the high clinical relevance of dual-task balance and gait performance, it is essential that stroke rehabilitation adequately addresses dual-task deficits. Developing specific dual-task balance and gait training to enhance dual-task performance is thus necessary to promote community ambulation and reintegration.

Study Aim This will be a single-blinded randomized controlled trial (RCT).The aim of this study is to examine the efficacy of a dual-task exercise program on cognitive-motor interference in balance and walking tasks, balance self-efficacy, participation in everyday activities, community reintegration and incidence of falls among individuals with chronic stroke.

Detailed description: Introduction Many individuals after stroke continue to cope with residual physical impairments after discharge from hospital. One of the major problems encountered by people after stroke is community reintegration. Functional community ambulation not only requires a critical level of postural control and walking skills, but also the ability to engage in cognitive tasks while walking (i.e., dual-task walking) and adapt to the constantly-changing environmental contexts. There has been an increasing awareness of the importance of dual-task gait performance in community-dwelling individuals with stroke in the past few years.

There is evidence showed that dual-task balance and gait performance is significantly impaired after stroke. Increasing evidence also suggests that dual-task balance and gait performance is useful for predicting falls among individuals with stroke. Considering the high clinical relevance of dual-task balance and gait performance, it is essential that stroke rehabilitation adequately addresses dual-task deficits. Developing specific dual-task balance and gait training to enhance dual-task performance is thus necessary to promote community ambulation and reintegration.

Study Aim The aim of this study is to examine the efficacy of a dual-task exercise program on cognitive-motor interference in balance and walking tasks, balance self-efficacy, participation in everyday activities, community reintegration and incidence of falls among individuals with chronic stroke.

Study design

This will be a single-blinded randomized controlled trial (RCT). After baseline evaluation, subjects will be randomly allocated to one of the three groups: (1) dual-task training group, (2) single-task training group, (3) strengthening and flexibility exercise group (controls), using a 1:1:1 randomization sequence.

Measurements Outcomes will be used to compare the therapeutic effects of the 3 treatment groups. The outcome measurements (except data on incidence of falls) will take place at 3 time points: (1) within one week before initiation of intervention (baseline), (2) within one week after completion of training, (3) 8 weeks after completion of training. The fall data will be collected on a monthly basis until 6 months after termination of the intervention period. All assessments will be performed by a researcher who is blinded to group allocation.

Eligibility criteria: Inclusion Criteria:

* diagnosis of a stroke
* more than 6 months of stroke onset
* aged 50 years or above
* community-dwelling
* medically stable
* score ≥21 on the Montreal Cognitive Assessment (MoCA)
* score ≤ 25 on the Mini Balance Evaluation Systems Test (Mini-BESTest)
* able to ambulate without physical assistance of another person as determined during the 10-meter walk test
* ability to follow 3-step commands

Exclusion Criteria:

* having neurological conditions other than stroke
* not community-dwelling prior to the stroke event
* significant receptive and expressive aphasia
* severe and uncorrected hearing or visual deficits
* serious musculoskeletal disorders (e.g. amputation)
* serious cardiovascular conditions affecting the ability to participate in exercise training
* pain experienced at rest or movement
* other serious illnesses that preclude participation

Primary outcomes:
measure: Timed-up-and-go test with and without dual-task
timeFrame: week 0
measure: Timed-up-and-go test with and without dual-task
timeFrame: week 8
measure: Timed-up-and-go test with and without dual-task
timeFrame: week 16
Secondary outcomes:
measure: 10-meter walk test with and without dual-task
timeFrame: week 0
measure: 10-meter walk test with and without dual-task
timeFrame: week 8
measure: 10-meter walk test with and without dual-task
timeFrame: week 16
measure: Sensory organization test with and without dual-task
timeFrame: week 0
measure: Sensory organization test with and without dual-task
timeFrame: week 8
measure: Sensory organization test with and without dual-task
timeFrame: week 16
measure: Obstacle crossing with and without dual-task
timeFrame: week 0
measure: Obstacle crossing with and without dual-task
timeFrame: week 8
measure: Obstacle crossing with and without dual-task
timeFrame: week 16
measure: Mini-Balance Evaluations Systems Test
timeFrame: week 0
measure: Mini-Balance Evaluations Systems Test
timeFrame: week 8
measure: Mini-Balance Evaluations Systems Test
timeFrame: week 16
measure: Activities-specific balance confidence scale
timeFrame: week 0
measure: Activities-specific balance confidence scale
timeFrame: week 8
measure: Activities-specific balance confidence scale
timeFrame: week 16
measure: Stroke Specific Quality of Life Scale
timeFrame: week 0
measure: Stroke Specific Quality of Life Scale
timeFrame: week 8
measure: Stroke Specific Quality of Life Scale
timeFrame: week 16
measure: Motricity Index
timeFrame: week 0
measure: Motricity Index
timeFrame: week 8
measure: Motricity Index
timeFrame: week 16
measure: Chedoke Arm and Hand Activity Inventory
timeFrame: week 0
measure: Chedoke Arm and Hand Activity Inventory
timeFrame: week 8
measure: Chedoke Arm and Hand Activity Inventory
timeFrame: week 16
measure: Frenchay Activities Index
timeFrame: week 0
measure: Frenchay Activities Index
timeFrame: week 8
measure: Frenchay Activities Index
timeFrame: week 16
measure: Tinetti Assessment Tool (Gait)
timeFrame: week 0
measure: Tinetti Assessment Tool (Gait)
timeFrame: week 8
measure: Tinetti Assessment Tool (Gait)
timeFrame: week 16
measure: Incidence of fall
timeFrame: week 0-6 months after training
measure: Global Rating of Change score
timeFrame: week 8
measure: Global Rating of Change score
timeFrame: week 16
measure: Upper limb muscle strength
timeFrame: week 0
measure: Upper limb muscle strength
timeFrame: week 8
measure: Upper limb muscle strength
timeFrame: week 16
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: Hong Kong Polytechnic University
Study officials:
affiliation: Hong Kong Polytechnic University
name: Marco YC Pang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Said CM, Galea MP, Lythgo N. People with stroke who fail an obstacle crossing task have a higher incidence of falls and utilize different gait patterns compared with people who pass the task. Phys Ther. 2013 Mar;93(3):334-44. doi: 10.2522/ptj.20120200. Epub 2012 Oct 11.
citation: Cockburn J, Haggard P, Cock J, Fordham C. Changing patterns of cognitive-motor interference (CMI) over time during recovery from stroke. Clin Rehabil. 2003 Mar;17(2):167-73. doi: 10.1191/0269215503cr597oa.
citation: Silsupadol P, Lugade V, Shumway-Cook A, van Donkelaar P, Chou LS, Mayr U, Woollacott MH. Training-related changes in dual-task walking performance of elderly persons with balance impairment: a double-blind, randomized controlled trial. Gait Posture. 2009 Jun;29(4):634-9. doi: 10.1016/j.gaitpost.2009.01.006. Epub 2009 Feb 7.
citation: Pichierri G, Wolf P, Murer K, de Bruin ED. Cognitive and cognitive-motor interventions affecting physical functioning: a systematic review. BMC Geriatr. 2011 Jun 8;11:29. doi: 10.1186/1471-2318-11-29.
citation: Yang YR, Wang RY, Chen YC, Kao MJ. Dual-task exercise improves walking ability in chronic stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2007 Oct;88(10):1236-40. doi: 10.1016/j.apmr.2007.06.762.
citation: Pang MYC, Yang L, Ouyang H, Lam FMH, Huang M, Jehu DA. Dual-Task Exercise Reduces Cognitive-Motor Interference in Walking and Falls After Stroke. Stroke. 2018 Dec;49(12):2990-2998. doi: 10.1161/STROKEAHA.118.022157.