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Cerebellar AtaxiaPhase 1EngageAtaxiaNCT05157802

Promoting Physical Activity Engagement for People With Early-stage Cerebellar Ataxia

A Phase 1 study testing Physical activity coaching in people with Cerebellar Ataxia, run by Teachers College, Columbia University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Engage-Ataxia will implement a physical activity coaching program for people with cerebellar ataxia at Teachers College, Columbia University. This program expands upon the current Engage program for people with Parkinson's disease (Engage-PD), an exercise coaching program for people with early stage Parkinson's… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Cerebellar Ataxia
What is being tested?
Physical activity coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
26 Mar 2021to 31 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Neurologist confirmed diagnosis of cerebellar ataxia
  • Scale for Ataxia Rating and Assessment (SARA) score between 8-25 (total score of 40), which will capture mild to moderate stage of the disease
  • Ambulatory for indoor and outdoor mobility without assistance or assistive device
  • Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) or medical clearance from primary doctor
  • Medical clearance to exercise

Who cannot join

  • Musculoskeletal injury that would prevent participation in an exercise program
  • Other neurological disease or disorder such as stroke
  • Cardiac/pulmonary conditions that would affect participants ability to participate exercise program
  • Metabolic conditions that would affect participants during an exercise program
  • Currently do moderate-vigorous exercise 5 days a week or more

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Teachers College, Columbia University

    New York, New York, 10027

Other trials in United States

About this study

Official title: Promoting Physical Activity Engagement for People With Early-stage Cerebellar Ataxia (EngageAtaxia)

Engage-Ataxia will implement a physical activity coaching program for people with cerebellar ataxia at Teachers College, Columbia University. This program expands upon the current Engage program for people with Parkinson's disease (Engage-PD), an exercise coaching program for people with early stage Parkinson's disease to target individuals with early stage cerebellar ataxia. Engage-Ataxia will utilize a physical or occupational therapist to provide up to five one-on-one coaching sessions for individuals newly diagnosed with cerebellar ataxia. Therapists will work with participants to provide individualized structured support to facilitate and optimize exercise uptake as one part of comprehensive disease management. Participants will undertake two assessments three months apart, and will receive coaching interventions via Zoom healthcare platform. The primary objective of this program is to increase physical activity and exercise engagement in individuals with early stage cerebellar ataxia. This feasibility study will provide preliminary data and insight into the benefits of a remote coaching intervention for people with cerebellar ataxia.

Being tested
Physical activity coaching
Keywords
physical activity, physical therapy, balance training, physical activity coaching, neurodegenerative disease, rehabilitation
Medical subject headings
Cerebellar Ataxia, Motor Activity, Neurodegenerative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activity coachingBehavioural

    Physical activity coaching over 5 sessions

Study groups in NCT05157802
Study groupRoleWhat they receive
Physical Activity CoachingExperimentalParticipants will receive up to 5 individualized coaching sessions delivered via telehealth to facilitate and optimize exercise uptake. The therapist will facilitate discussion on specific and measurable goals, and will provide options for tracking their progress, such as written or web-based exercise logs or an activity monitor. The recommended exercises will be individualized to each participant but will primarily focus on increasing general physical activity (e.g. steps per day) as well as engagement in moderate intensity aerobic exercise a minimum of three times per week. Balance and strengthening exercises will also be recommended as appropriate.
Receives: Behavioral: Physical activity coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Scale for Assessment and Rating for Ataxia

    Clinical rating scale for severity of ataxia symptoms. This is an 8-item clinical performance based scale, which individuals are graded according to total ataxia severity. Total scores can range from 0 (no ataxia) to 40 (most severe ataxia). Scores are based on performance of the following tasks: 1) Gait, 2) Stance, 3), Sitting, 4) Speech Disturbance, 5) Finger Chase, 6) Nose-Finger Test, 7) Fast alternating hand movements, 8) Heel-shin slide. For the purpose of this study, we will be performing a modified version of the SARA, and be using the first four items of the SARA Scale (Gait, Stance, Walking, Speech) to be administered via telehealth.

    Measured: Baseline, Post-Intervention (3 months)

  2. Change in Cerebellar Cognitive Affective Syndrome Scale

    The Cerebellar Cognitive Affective Syndrome Scale (CCAS) was developed as a bedside quick screen for Cerebellar Cognitive Affective Symptom (also referred to as Schmalmann's Syndrome). The CCAS is a 10-item scale of cognitive and neuropsychiatric tests detailing executive function, working and verbal memory, language, visuospatial function, abstract reasoning, behavior and affect. Two scores are reported; a raw score ranging from 0 (severe cognitive impairment) to 120 points (no cognitive impairment), as well as a Pass/Fail marker for each of the 10 items on the scale. 1 fail is considered as possible cerebellar cognitive affective symptom, 2 fails are considered probable, and 3 fails are considered clinically definite.

    Measured: Baseline, Post-Intervention (3 months)

  3. Change in Brunel Lifestyle Physical Activity Questionnaire

    Evaluates both pre-planned and unplanned physical activity. Both pre-planned and unplanned physical activity subsections are separately scored through summation and average. Higher averages (closer to 5) indicate greater physical activity, whereas lower averages (closer to 0) indicate little to no physical activity in either category.

    Measured: Baseline, Post-Intervention (3 months)

Secondary outcomes (6)

  1. Exercise Identity Scale Exercise Identity Scale

    Questions pertaining to salience of exercise identity. Scores range from 0 (no exercise identity) to 45 (high degree of exercise identity).

    Measured: Baseline, Post-Intervention (3 months)

  2. The Self- Efficacy for Exercise Scale

    Assesses an individual's beliefs in their ability to engage with exercise. Scores range from 0 (no exercise self-efficacy) to 90 (high exercise self efficacy).

    Measured: Baseline, Post-Intervention (3 months)

  3. Activities Specific Balance Scale (ABC)

    This assessment is a patient reported outcome evaluating the balance confidence of a participant in performing a variety of activities without losing balance or experiencing a state of unsteadiness. Participants are asked to rank their perceived balance confidence on a scale of 0% (no balance confidence) to 100% (high balance confidence). All scores are summed, and averaged for a total overall estimate of balance confidence.

    Measured: Baseline, Post-Intervention (3 months)

  4. Digital Biomarker of Static Posturography

    Participant will perform static standing with feet together and postural sway will be recorded with a smart phone app.

    Measured: Baseline, Post-Intervention (3 months)

  5. Digital Biomarker of Dynamic Posturography

    Participant will perform the Timed Up and Go Test (TUG) which consists of standing from a seated position, walking forward 10 feet, turning around, walking back 10 feet, and then returning to a seated position. The TUG test will be recorded with a smart phone app.

    Measured: Baseline, Post-Intervention (3 months)

  6. Acceptability Questionnaire

    A short open-ended questionnaire to assess the acceptability of the intervention. These open-ended questions will be analyzed qualitatively.

    Measured: Post-intervention (3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2021
  2. Study start26 Mar 2021
  3. Primary completion30 Sep 2022
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05157802
Sponsor's protocol ID
21-042
Acronym
EngageAtaxia
Status last verified
May 2024
First submitted
24 Nov 2021
Last updated
3 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Macpherson CE, Kempner K, King M, Kaplan M, Pacheco A, Wani D, Kuo SH, Quinn L. Feasibility of a Telehealth Physical Activity Coaching Intervention for Degenerative Cerebellar Ataxia. J Neurol Phys Ther. 2025 Oct 1;49(4):201-213. doi: 10.1097/NPT.0000000000000516. Epub 2025 Sep 16.

    PubMed 41171420

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Physical activity coaching in people with Cerebellar Ataxia, run by Teachers College, Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Scale for Assessment and Rating for Ataxia (time frame: Baseline, Post-Intervention (3 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05157802, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.

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