Dual Task Training for Cerebellar Ataxia
Condition: Cerebellar Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia
Study type: Interventional

Summary: 
      Combining cognitive training with physical training to improve balance is a new approach for
      reducing the risk of falls in patient populations who are at risk for falls. People with
      brain pathology including cerebellar ataxia (CA) have difficulty in performing dual-tasks.
      Deficiency in dual-task performance relative to single-task performance referred to as
      dual-task cost is high in CA. Due to the high demands on cognitive resources, people with CA
      have higher falls rates during activities that involve dual tasking. Tai-Chi involves both
      cognition and physical movements making it a dual-tasking activity. However, previous study
      on the effects of 12-weeks of 8-form Tai-Chi did not demonstrate that it had beneficial
      effects in reducing falls among CA population. This null finding could potentially be due to
      (1) the lower levels of cognitive demands of Tai-Chi exercise, (2) the intervention not being
      intensive enough, or (3) the intervention may not have targeted the specific symptoms of CA.
      To determine if adding structured cognitive demands to conventional balance and coordination
      training (i.e., addressing all three possibilities for our previous null findings), the
      investigaotrs conducted a pilot study (n=5) to evaluate the feasibility, safety and benefits
      of a Cognitive-coupled Intensive Balance Training (CIBT) program. The more intensive and
      focused CIBT intervention reduced dual-task cost, improved balance, and reduced the number of
      falls in a sample of individuals with CA. Important next steps is to (1) evaluate the
      efficacy of the CIBT in a fully powered clinical trial, (2) understand the mechanisms
      underlying the benefits of CIBT training, and (3) determine the cost-benefits of this
      intervention. The hypothesis for the study includes (1) CIBT will improve balance and reduce
      falls; (2) reduction in dual-task cost of balance and cognitive performance will mediate a
      reduction in the number of falls in CA and (3) CIBT will be a cost-effective treatment option
      for improving balance and reduce falls. To test these hypotheses, a randomized controlled
      trial (RCT) with economic evaluation will be conducted over a period of two years to evaluate
      the effectiveness and cost-effectiveness of dual-task (CIBT) training compared with
      single-task (conventional balance: active control) training in individuals with CA.
    

Detailed description: 
      Frequent falls in people with cerebellar ataxia (CA) is a significant problem because it
      increases the burden of disease to both the individual and the healthcare system. Therefore,
      an intervention that could improve balance and reduce the number of falls is of paramount
      importance from the patients' perspective. Although the incidence of CA in the population is
      not as high as the other neurological disorders such as stroke and Parkinson's disease, the
      disability and its negative impact on quality of life are significant for those suffering
      from CA. Moreover, research that results in more knowledge regarding the factors that
      contribute to falls and the efficacy of treatments that reduce falls in this population could
      inform research into fall prevention in other populations of individuals at risk for falls,
      including otherwise healthy elderly adults. Individuals with CA have poor coordination,
      balance and postural control; all of these contribute to them having frequent falls. People
      with CA also present with varying degrees of cognitive impairments making it difficult for
      them to perform dual-tasks in daily activities. Dual tasking has been found to deteriorate
      the performance of either or both tasks in people with CA. The deficiency in dual-task
      performance relative to single-task performance referred to as dual-task cost is high in CA.
      Falls incidence in people with CA increases during daily activities that involve dual
      tasking. Tai-Chi is a form of dual-task training. Previous study of the Tai-Chi to improve
      balance and prevent falls in people with CA found some beneficial effects of Tai-Chi on
      improving balance, but it did not reduce falls incidence. The investigaotrs speculate the
      lack of beneficial effects of Tai-Chi on falls incidence was due to the Tai-Chi intervention
      being inadequately intense, especially with respect to its cognitive demand. Other available
      interventions to improve balance and reduce falls do not address the dual-task cost of
      balance performance in this population. However, dual-task training is found to reduce
      dual-task cost and reduce falls in people other neurological disorders and therefore has the
      potential to reduce falls in CA. To evaluate this possibility, the investigators developed
      and piloted the Cognitive-coupled Intensive Balance Training (CIBT) that combines cognitive
      demand to intensive balance and coordination training for reducing the dual-task cost of
      balance and cognitive performance, improve balance and consequently reduce the number of
      falls. The pilot study found that CIBT is safe, feasible and potentially effective in
      reducing the dual-task cost of balance performance, improving functional balance and reducing
      falls in people with CA. Evaluating the efficacy of this program in a fully powered clinical
      trial and understanding the mechanisms underlying the effectiveness of the CIBT on balance
      and falls are important next steps of our research program. Here the investigators propose a
      randomized controlled trial (RCT) to compare the treatment benefits of the dual-task
      (experimental: CIBT) training against the single-task (active control: conventional balance,
      coordination and cognition) training for reducing dual-task cost, improving balance and
      reduce the number of falls in participants with CA, evaluating both the efficacy and the
      mechanisms of dual-task training. In addition, the investigators propose to conduct an
      economic evaluation alongside the RCT at a healthcare perspective of Hong Kong to compare the
      cost-effectiveness of dual-task training against single-task training, in preparation for the
      development of any future trials. This study finding will have important clinical
      implications by clarifying if adding a cognitive demand to routine balance and coordination
      training will result in additional benefits on improving balance and reducing falls in
      comparison with usual care in people with CA. The findings will also have important
      implications for increasing the efficacy of falls prevention programs in other populations
      with neurological deficits who are at risk for falls. Our specific objectives are:

      Objective 1: To evaluate the effectiveness of the dual-task (CIBT- experimental) training
      compared with single task (conventional intensive balance, coordination and cognitive- active
      control) training on functional balance and number of falls.

      Hypothesis 1: Both dual-task and single-task training will improve functional balance,
      however, the dual-task training will be more effective in reducing the number of falls.

      Objective 2: To identify the mechanism underlying the effectiveness of the dual-task training
      on functional balance and the number of falls; that is, to evaluate the extent to which
      treatment-related changes in the functional balance and dual-task cost of balance and
      cognitive performance mediate the reduction in the number of falls.

      Hypothesis 2: Improvement in functional balance resulting in the reduction of number of falls
      will be mediated by the reduction in the dual-task cost of balance and cognitive
      performances.

      Objective 3: Compare the cost-effectiveness of the dual-task and single-task training for
      preventing falls.

      Hypothesis 3: Dual-task training will be superior in terms of cost-effectiveness than the
      single-task from a health-care perspective of Hong Kong
    

Intervention name(s): Dual-task training
Intervention type(s): Other
Intervention description(s): Dual-task (CIBT- experimental) group participants will receive 10 minutes of warm up, 40 minutes of CIBT training and 10 minutes of cool down exercises. CIBT program includes performing four types of cognitive tasks during sit to stand, standing with feet apart, one leg, tandem standing, multidirectional reaching, stair climbing and walking (10 metres) tasks. The four cognitive tasks will include: counting backwards by subtracting 4 numbers (for mental tracking ), naming fruits, vegetables, or animals (for working memory), auditory cues for performing activities, example, perform heel raise when you hear the alphabet H (for improving attention and auditory discrimination), short story telling (for verbal fluency). In addition, falls prevention strategies will be taught.
Other intervention name(s): Physical and cognitive exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An assessor and statistician blinded two-arm parallel group, RCT comparing dual-task (CIBT) to single-task (conventional balance, coordination and cognitive) training will be conducted with 44 participants with CA. Eligible participants will be randomized to study groups and allocation will be concealed. Participants will be randomized to one of the two groups: Group 1: Dual-task (CIBT) training; and Group 2: Single-task active control (conventional balance, coordination and cognition) training.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dual-task; Balance training; Fall prevention; Economic evaluation