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PRIME-Ataxia RCT

PRIME-Ataxia RCT

This study aims to determine the feasibility and efficacy of an 8-week remote intervention of high intensity aerobic exercise prior to balance training compared to an 8-week remote intervention low intensity exercise prior to balance training in individuals diagnosed with spinocerebellar ataxias (SCAs).

Study Flier: Download Now

About the Study

Eligible Ataxia Types
Spinocerebellar Ataxia Types 1, 2, 3, 6, or 7

Type of Study
Research Study

Clinical Trial Phase
N/A

Age Range
Adult 18+

Study Start Date
01/01/2023

Estimated Completion Date
12/31/2023

IRB Approval #
23-088

Location(s)

Teachers College, Columbia University
Remote Study

Contact Information

Chelsea Macpherson
Email: cem2183@cumc.columbia.edu
Phone: 212-678-3916

What does participation in the study entail?

  1. Telephone Screening & Informed Consent (30 minutes)
  2. Care-Partner Training Webinar (30 minutes)
  3. 4 Remote Assessments (Baseline Week 0, Baseline Week 8, Mid-Intervention Week 12, Post-Intervention Week 16)
  4. 2 Online Assessments of Motor Learning (30-45 min each)
  5. 8 Week Observation Period (you wear a fitbit during this time, we monitor steps, heart rate, physical activities)
  6. 8 Week Intervention Period: Sessions 2x/week on Zoom with One-on-One with Neuro PT (45-60 minutes/session; 16 sessions total)

What are the potential benefits for participants?

Participants could benefit from receiving the guided exercise intervention from a physical therapist who has expertise in working with people with cerebellar ataxia. Additionally, participants will recieve a fitbit charge HR5.

What are the potential risks for participants?

This is a low-risk intervention and we aim to mitigate risk for adverse events. We have used guidelines set by the American College of Cardiology, the American Heart Association, and the American College of Sports Medicine in regard to vital sign monitoring, and exercise testing/prescription. Minor muscle soreness or muscular strain may occur in the few days following the initiation of a new exercise program or increase physical activity, however this is likely to resolve. Falls are an expected adverse event, however, as a team, we are doing everything that we can to try and mitigate this risk, such as training care-partners on how to guard participants appropriately for these assessments and set up the home environment for successful assessment as well as intervention.

Is there financial compensation?

No.

Is there travel reimbursement?

No. Not applicable.

Who is eligible?

  1. Between the ages of 18 to 85 years
  2. Genetically confirmed diagnosis of SCA1, 2, 3, 6, and 7
  3. Scale for Ataxia Rating and Assessment (SARA) score between 8-25/40, capturing mild-moderate disease.
  4. Able to walk with/without assistive device
  5. Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) to confirm no medical contraindications to exercise
  6. Potential care partner availability for assessments and/or intervention pending balance scores
  7. No known cardiac/pulmonary conditions that would affect participants ability to participate exercise program
  8. No severe visual complications associated with ataxia (i.e., Spontaneous nystagmus, retinal or optic nerve involvement, especially in SCA7)
  9. No other concurrent disease of the cerebellum (e.g. stroke, multiple sclerosis)
  10. No musculoskeletal injury that would prevent participation in an exercise program
  11. Not currently engaged in >3 week moderate-high intensity aerobic exercise and/or balance training

Additional Information or Resources

Patient Flier: Download Now

View Other Research Opportunities

PRIME-Ataxia RCT

This study aims to determine the feasibility and efficacy of an 8-week remote intervention of high intensity aerobic exercise prior to balance training compared to an 8-week remote intervention low Read More…

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Read More »
Print Friendly, PDF & Email

This study aims to determine the feasibility and efficacy of an 8-week remote intervention of high intensity aerobic exercise prior to balance training compared to an 8-week remote intervention low intensity exercise prior to balance training in individuals diagnosed with spinocerebellar ataxias (SCAs).

Study Flier: Download Now

About the Study

Eligible Ataxia Types
Spinocerebellar Ataxia Types 1, 2, 3, 6, or 7

Type of Study
Research Study

Clinical Trial Phase
N/A

Age Range
Adult 18+

Study Start Date
01/01/2023

Estimated Completion Date
12/31/2023

IRB Approval #
23-088

Location(s)

Teachers College, Columbia University
Remote Study

Contact Information

Chelsea Macpherson
Email: cem2183@cumc.columbia.edu
Phone: 212-678-3916

What does participation in the study entail?

  1. Telephone Screening & Informed Consent (30 minutes)
  2. Care-Partner Training Webinar (30 minutes)
  3. 4 Remote Assessments (Baseline Week 0, Baseline Week 8, Mid-Intervention Week 12, Post-Intervention Week 16)
  4. 2 Online Assessments of Motor Learning (30-45 min each)
  5. 8 Week Observation Period (you wear a fitbit during this time, we monitor steps, heart rate, physical activities)
  6. 8 Week Intervention Period: Sessions 2x/week on Zoom with One-on-One with Neuro PT (45-60 minutes/session; 16 sessions total)

What are the potential benefits for participants?

Participants could benefit from receiving the guided exercise intervention from a physical therapist who has expertise in working with people with cerebellar ataxia. Additionally, participants will recieve a fitbit charge HR5.

What are the potential risks for participants?

This is a low-risk intervention and we aim to mitigate risk for adverse events. We have used guidelines set by the American College of Cardiology, the American Heart Association, and the American College of Sports Medicine in regard to vital sign monitoring, and exercise testing/prescription. Minor muscle soreness or muscular strain may occur in the few days following the initiation of a new exercise program or increase physical activity, however this is likely to resolve. Falls are an expected adverse event, however, as a team, we are doing everything that we can to try and mitigate this risk, such as training care-partners on how to guard participants appropriately for these assessments and set up the home environment for successful assessment as well as intervention.

Is there financial compensation?

No.

Is there travel reimbursement?

No. Not applicable.

Who is eligible?

  1. Between the ages of 18 to 85 years
  2. Genetically confirmed diagnosis of SCA1, 2, 3, 6, and 7
  3. Scale for Ataxia Rating and Assessment (SARA) score between 8-25/40, capturing mild-moderate disease.
  4. Able to walk with/without assistive device
  5. Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) to confirm no medical contraindications to exercise
  6. Potential care partner availability for assessments and/or intervention pending balance scores
  7. No known cardiac/pulmonary conditions that would affect participants ability to participate exercise program
  8. No severe visual complications associated with ataxia (i.e., Spontaneous nystagmus, retinal or optic nerve involvement, especially in SCA7)
  9. No other concurrent disease of the cerebellum (e.g. stroke, multiple sclerosis)
  10. No musculoskeletal injury that would prevent participation in an exercise program
  11. Not currently engaged in >3 week moderate-high intensity aerobic exercise and/or balance training

Additional Information or Resources

Patient Flier: Download Now

View Other Research Opportunities

PRIME-Ataxia RCT

This study aims to determine the feasibility and efficacy of an 8-week remote intervention of high intensity aerobic exercise prior to balance training compared to an 8-week remote intervention low Read More…

Print Friendly, PDF & Email
Read More »
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