Dual-task Training in Chronic Stroke

Stroke Clinical Trial

Official title:

Training Dual-task Balance and Walking in Community-dwelling Older Adults With Chronic Stroke: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02270398
• Other study ID #: HSEARS20140714003-01
• Status: Recruiting
• Phase: N/A
• First received: October 17, 2014
• Last updated: November 9, 2014
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: November 2014
• Source: The Hong Kong Polytechnic University
• Contact: Echo Ouyang, BSc
• Phone: 27664844
• Email: echo.y.ouyang[@]polyu.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Research Office, The Hong Kong Polytechnic University
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Dual-task training group
Balance and gait exercises while simultaneously engaging in a secondary cognitive task.
• Single-task training group
Balance/gait exercises and cognitive exercises done separately.
• Flexibility and strength training group
Whole-body flexibility exercises, upper limb strengthening exercises.

Locations

Country	Name	City	State
Hong Kong	Hong Kong Polytechnic University	Hung Hom

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	West China Hospital

Country where clinical trial is conducted

Hong Kong, 

References & Publications (5)

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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed-up-and-go test with and without dual-task	A walking test	week 0	No
Primary	Timed-up-and-go test with and without dual-task	A walking test	week 8	No
Primary	Timed-up-and-go test with and without dual-task	A walking test	week 16	No
Secondary	10-meter walk test with and without dual-task	A walking test	week 0	No
Secondary	10-meter walk test with and without dual-task	A walking test	week 8	No
Secondary	10-meter walk test with and without dual-task	A walking test	week 16	No
Secondary	Sensory organization test with and without dual-task	A standing balance test	week 0	No
Secondary	Sensory organization test with and without dual-task	A standing balance test	week 8	No
Secondary	Sensory organization test with and without dual-task	A standing balance test	week 16	No
Secondary	Obstacle crossing with and without dual-task	A walking test	week 0	No
Secondary	Obstacle crossing with and without dual-task	A walking test	week 8	No
Secondary	Obstacle crossing with and without dual-task	A walking test	week 16	No
Secondary	Mini-Balance Evaluations Systems Test	A balance test	week 0	No
Secondary	Mini-Balance Evaluations Systems Test	A balance test	week 8	No
Secondary	Mini-Balance Evaluations Systems Test	A balance test	week 16	No
Secondary	Activities-specific balance confidence scale	A questionnaire	week 0	No
Secondary	Activities-specific balance confidence scale	A questionnaire	week 8	No
Secondary	Activities-specific balance confidence scale	A questionnaire	week 16	No
Secondary	Stroke Specific Quality of Life Scale	A questionnaire	week 0	No
Secondary	Stroke Specific Quality of Life Scale	A questionnaire	week 8	No
Secondary	Stroke Specific Quality of Life Scale	A questionnaire	week 16	No
Secondary	Motricity Index	A muscle strength test	week 0	No
Secondary	Motricity Index	A muscle strength test	week 8	No
Secondary	Motricity Index	A muscle strength test	week 16	No
Secondary	Chedoke Arm and Hand Activity Inventory	An arm function test	week 0	No
Secondary	Chedoke Arm and Hand Activity Inventory	An arm function test	week 8	No
Secondary	Chedoke Arm and Hand Activity Inventory	An arm function test	week 16	No
Secondary	Frenchay Activities Index	A questionnaire	week 0	No
Secondary	Frenchay Activities Index	A questionnaire	week 8	No
Secondary	Frenchay Activities Index	A questionnaire	week 16	No
Secondary	Tinetti Assessment Tool (Gait)	A walking test	week 0	No
Secondary	Tinetti Assessment Tool (Gait)	A walking test	week 8	No
Secondary	Tinetti Assessment Tool (Gait)	A walking test	week 16	No
Secondary	Incidence of fall	fall follow-up using log book and monthly telephone calls	week 0-6 months after training	No
Secondary	Global Rating of Change score	A questionnaire	week 8	No
Secondary	Global Rating of Change score	A questionnaire	week 16	No
Secondary	Upper limb muscle strength	dynamometry test	week 0	No
Secondary	Upper limb muscle strength	dynamometry test	week 8	No
Secondary	Upper limb muscle strength	dynamometry test	week 16	No