Skip to content

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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05157802
Acronym
EngageAtaxia
Enrollment
30
Registered
2021-12-15
Start date
2021-03-26
Completion date
2024-12-31
Last updated
2024-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebellar Ataxia

Keywords

physical activity, physical therapy, balance training, physical activity coaching, neurodegenerative disease, rehabilitation

Brief 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 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.

Interventions

Physical activity coaching over 5 sessions

Sponsors

Teachers College, Columbia University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Scale for Assessment and Rating for AtaxiaBaseline, Post-Intervention (3 months)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.
Change in Cerebellar Cognitive Affective Syndrome ScaleBaseline, Post-Intervention (3 months)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.
Change in Brunel Lifestyle Physical Activity QuestionnaireBaseline, Post-Intervention (3 months)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.

Secondary

MeasureTime frameDescription
Digital Biomarker of Static PosturographyBaseline, Post-Intervention (3 months)Participant will perform static standing with feet together and postural sway will be recorded with a smart phone app.
Exercise Identity Scale Exercise Identity ScaleBaseline, Post-Intervention (3 months)Questions pertaining to salience of exercise identity. Scores range from 0 (no exercise identity) to 45 (high degree of exercise identity).
Acceptability QuestionnairePost-intervention (3 months)A short open-ended questionnaire to assess the acceptability of the intervention. These open-ended questions will be analyzed qualitatively.
Digital Biomarker of Dynamic PosturographyBaseline, Post-Intervention (3 months)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.
The Self- Efficacy for Exercise ScaleBaseline, Post-Intervention (3 months)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).
Activities Specific Balance Scale (ABC)Baseline, Post-Intervention (3 months)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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026