Training Dual-task Balance and Walking in People With Stroke

Stroke Clinical Trial

Official title:

Training Dual-task Balance and Walking in People With Stroke: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02753322
• Other study ID #: KC/KE-15-0185/ER-3
• Status: Recruiting
• Phase: N/A
• First received: April 24, 2016
• Last updated: April 26, 2016
• Start date: April 2016
• Est. completion date: March 2018

Study information

• Verified date: April 2016
• Source: The Queen Elizabeth Hospital
• Contact: Margaret WY POON, MSc
• Phone: 852-3506 2603
• Email: pwy751[@]ha.org.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Stroke is one of the most common chronic disabling conditions in Hong Kong. People after stroke may suffer from certain degree of physical impairment and disability. Resuming safe ambulation in the community appears to be a big challenge to them as it always involves the simultaneous performance of two or more tasks (dual task) such as walking and talking with someone, walking and recalling the shopping list etc. Numerous studies has demonstrated that the interference from dual tasks (dual task interference) may significantly impact the recovery of the functional walking. To date, the relevance of dual task walking to daily community is widely documented and the ability of managing dual task is therefore particularly important. Evidences supported that dual task training showed its promising effect on the balance and walking performance amongst people with neurological disorders, such as chronic stroke. In light of this, the introduction of dual task based balance and walking training into physiotherapy program for stroke patient may enhance the balance and walking performance and hence promote successful community ambulation. Yet, there is limited evidence on its effect in sub-acute stroke.

Objective: To examine the effectiveness of a dual-task based balance and walking training program on performance and dual task interference in balance and walking ability, balance self-efficacy and incidence of falls in people with sub-acute stroke

Description:

An assessor-blind, randomized control trial will be conducted. Eighty-four people with sub-acute stroke and fulfill the eligibility criteria will be recruited from the medical wards of the Queen Elizabeth Hospital (QEH) or from the Physiotherapy Department of the QEH. Subjects will be randomly allocated into either dual-task training (DT) group (n=28) or single-task training (ST) group (n=28) or Control (C) group (n=28) by 1:1:1 randomization sequence after baseline evaluation. All subjects will receive usual physiotherapy training. Subjects in the DT group will undergo 30 minutes of dual task training with simultaneously performing balance and walking exercise and attention demanding tasks, and 30 minutes of stretching exercises whereas those in the ST group will undergo single task training with 30 minutes of balance and walking exercise and 30 minutes of attention demanding task performed separately. Subjects in the control group will receive stretching and strengthening exercise only. The training program will last for 8 weeks with frequency of 2 sessions a week and duration of 60 minutes per session.

The degree of the dual-task interference, the balance and walking performance in dual task conditions will be evaluated at three time points: (1) Baseline (within one week before the intervention (2) within one week after completion of training (3) 8 weeks after the completion of training by blinded assessors. Also, the subjects will have monthly telephone follow up on the fall incidence for 6 months after completion of the program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: March 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 99 Years

Eligibility

Inclusion Criteria:

• Diagnosis of a stroke confirmed by the individual's physician, between 1 month and 6 months post-stroke onset

• Aged =50

• Community-dwelling prior to stroke onset (defined as living in one's own home or the home of a relative, friend or caregiver)

• Medically stable

• Montreal Cognitive Assessment (MoCA) scored =21

• Ability to follow 3-step commands

• Having motor impairment in the affected lower extremity [Chedoke McMaster Stroke Assessment (CMSA) leg and foot summative score of 4-13 out of 14)], and upper extremity (CMSA arm and hand summative score of 4-13 out of 14)

• Having balance deficits (Mini-Balance Evaluation Systems test score <24)

• Able to ambulate without physical assistance of another person as determined during the 10-meter walk test

Exclusion Criteria:

• Recurrent stroke

• Having neurological conditions other than stroke

• significant receptive and expressive aphasia

• Severe and uncorrected hearing or visual deficits

• Serious musculoskeletal (e.g. amputation) or cardiovascular conditions affecting the ability to exercise (e.g. congestive heart failure), pain experienced at rest or movement, and 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

Other:
• Dual task training
Balance and walking exercises with simultaneously engaging in attention demanding tasks
• Single-task training
Balance and walking exercises and and attention demanding task performed separately
• Limbs exercise
Stretching and strengthening exercises

Locations

Country	Name	City	State
China	Queen Elizabeth Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Queen Elizabeth Hospital	The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of the dual-task interference	It will be assessed by calculating the percentage of the difference between single task performance (2 walking tasks and 2 balance tasks) and dual task performance of the 2 walking tasks and 2 balance tasks while engaging in 3 attention demanding tasks.	Baseline, 8 weeks, 16 weeks	No
Secondary	Standing balance with eyes opened in dual task conditions	It will be evaluated by Smart Balance System (NeuroCom International Inc., Clackamas, USA). An equilibrium score will be obtained.	Baseline, 8 weeks, 16 weeks	No
Secondary	Standing balance with eyes closed in dual task conditions	It will be evaluated by Smart Balance System (NeuroCom International Inc., Clackamas, USA). An equilibrium score will be obtained.	Baseline, 8 weeks, 16 weeks	No
Secondary	10 metre walk test in dual task conditions	Subjects will be requested to walk along a 14-meter walkway at a self-selected speed. Time taken for the intermediate 10 meters will be recorded.	Baseline, 8 weeks, 16 weeks	No
Secondary	Obstacle crossing test in dual task conditions	Subjects will be asked to walk at their fastest safe speed to cross seven 4-cm-high obstacles along a 10 meters-walkway. Time taken to complete the task will be recorded.	Baseline, 8 weeks, 16 weeks	No
Secondary	Chinese version of Activities-specific Balance Confidence (ABC) Scale	Evaluating the subject's balance self efficacy	Baseline, 8 weeks, 16 weeks	No
Secondary	Chedoke Arm and Hand Activity Inventory (short form)	Performance-based measure for upper limb function	Baseline, 8 weeks, 16 weeks	No
Secondary	Incidence of falls	Fall incidence will be recorded using log book and monthly telephone calls	From baseline to 6 months	No