Dual Task Training for Cerebellar Ataxia

NCT04648501 | Completed

• 1 other identifier: P0030895
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebellar Ataxia

Keywords

Dual-task; Balance training; Fall prevention; Economic evaluation

Outcome Measures

Primary Outcomes (2)

• Dual-task cost of balance performance will be assessed for the TUG

  Based on the scores of the standard TUG (single task), d-TUG (dual-task TUG) test and standard counting backwards, the dual-task cost of balance performance will be estimated using the formula: (d-TUG - Standard TUG)/ Standard-TUG) × 100.

  0 weeks

• Dual-task cost of balance performance will be assessed for the TUG

  Based on the scores of the standard TUG (single task), d-TUG (dual-task TUG) test and standard counting backwards, the dual-task cost of balance performance will be estimated using the formula: (d-TUG - Standard TUG)/ Standard-TUG) × 100.

  Change score at 10 weeks and 34 weeks

Secondary Outcomes (7)

• SOT

  0 weeks, 6 weeks, 10 weeks and 34 weeks

• Limits of stability (LOS)

  0 weeks, 6 weeks, 10 weeks and 34 weeks

• Number of falls

  0 weeks, 6 weeks, 10 weeks and 34 weeks

• Montreal Cognitive Assessment (MoCA),

  0 weeks, 6 weeks, 10 weeks and 34 weeks

• Scale for the Assessment & Rating of Ataxia (SARA)

  0 weeks, 6 weeks, 10 weeks and 34 weeks

Study Arms (2)

Dual-task group

EXPERIMENTAL

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: Dual-task training

Single-task group

ACTIVE COMPARATOR

Single-task (conventional balance, coordination and cognitive training- active control) group participants will receive 10 minutes of warm-up, 20 minutes of conventional balance and coordination exercises that are in accordance to previously published literature, 20 minutes of cognitive training as single-task (same 4 tasks provided for the CIBT) and 10 minutes of cool down. In addition, falls prevention strategies will also be taught.

Other: Dual-task training

Interventions

Dual-task training OTHER

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.

Also known as: Physical and cognitive exercises

Dual-task group; Single-task group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women in the age group of 18-60 years;
• Confirmed diagnosis of CA (of any type);
• Able to walk independently with or without walking assistive aids.

You may not qualify if:

• Previous history of other neurological diseases (such as Parkinson's disease, stroke, or polyneuropathies) or musculoskeletal problems severely impairing balance, gait or motor performance;
• Able to walk only with handheld support
• Severe visual impairment preventing from exercise participation and
• Severe cognitive impairment with scores \<16 on the Montreal Cognitive Assessment (MoCA) scale

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Chinese University of Hong Kong: collaborator
• National University of Singapore: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Kowloon, 00, Hong Kong

Location

Related Publications (1)

• Winser SJ, Chan AYY, Whitney SL, Chen CH, Pang MYC. Effectiveness and cost of integrated cognitive and balance training for balance and falls in cerebellar ataxia: a blinded two-arm parallel group RCT. Front Neurol. 2024 Jan 19;14:1267099. doi: 10.3389/fneur.2023.1267099. eCollection 2023.

  PMID: 38313407 DERIVED

MeSH Terms

Conditions

Cerebellar Ataxia

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A person not involved in the study (student helper #1) will randomize participants to study groups in permuted blocks through computer-generated random numbers list prepared by The student helper who is not involved in the recruitment, assessment of study variables, or intervention delivery will perform the allocation of participants into the experimental group and active control groups. One other part-time research assistant will be recruited to conduct all the other methodological procedures of the project (RA2). Assessments will be performed by a PhD student of the PI who is blind to treatment condition. Statistical analysis will be performed by the PI who will be blind to treatment condition during analyses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: December 1, 2020
• Study Start: March 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: May 11, 2022

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)