Clinical trial NCT02753322: Training Dual-task Balance and Walking in People With Stroke
Official title: Training Dual-task Balance and Walking in People With Stroke: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Dual task training
Dual task interference
Sub-acute stroke
Physiotherapy training
Community ambulation
Balance
Lead sponsor: The Queen Elizabeth Hospital
Sponsor class: OTHER
Collaborators: name: The Hong Kong Polytechnic University
First posted: 2016-04-27
Enrollment: 84
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Degree of the dual-task interference
timeFrame: Baseline, 8 weeks, 16 weeks
Secondary outcomes:
measure: Standing balance with eyes opened in dual task conditions
timeFrame: Baseline, 8 weeks, 16 weeks
measure: Standing balance with eyes closed in dual task conditions
timeFrame: Baseline, 8 weeks, 16 weeks
measure: 10 metre walk test in dual task conditions
timeFrame: Baseline, 8 weeks, 16 weeks
measure: Obstacle crossing test in dual task conditions
timeFrame: Baseline, 8 weeks, 16 weeks
measure: Chinese version of Activities-specific Balance Confidence (ABC) Scale
timeFrame: Baseline, 8 weeks, 16 weeks
measure: Chedoke Arm and Hand Activity Inventory (short form)
timeFrame: Baseline, 8 weeks, 16 weeks
measure: Incidence of falls
timeFrame: From baseline to 6 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Elizabeth Hospital
Study officials:
affiliation: The Queen Elizabeth Hospital
name: Margaret WY POON, MSc
role: PRINCIPAL_INVESTIGATOR
References: