NCT05002218

Training in Ataxia - Individuals With Degenerative Cerebellar Diseases

Completed NA Results posted Last updated 4 November 2025

What this trial tests

NA trial testing Aerobic Training in Cerebellar Ataxia in 64 participants. Completed in 6 November 2024.

Timeline

31 January 2022

Primary endpoint
6 November 2024

6 November 2024

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	64
Start date	31 January 2022
Primary completion	6 November 2024
Estimated completion	6 November 2024
Sites	1 location across United States

Drugs / interventions tested

• Aerobic Training
• Balance Training

Conditions studied

• Cerebellar Ataxia — all drugs for Cerebellar Ataxia →

Sponsor

Columbia University

Who can join

18 and older, any sex, with Cerebellar Ataxia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Assessment and Rating of Ataxia (SARA) Score Primary · Baseline, 6 months, 9 months, 12 months

This is to measure ataxia severity. The Scale for the Assessment and Rating of Ataxia (SARA) will be administered before and after training. SARA is an 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia) - with higher scores indicating more severe ataxia. The scores are based on patient performance of gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating hand movements and heel-shin slide. The change in score from baseline to 6 months, 9 months, and 12 months will be reported.

Baseline to 6 months

Group	Value	95% CI
Aerobic Training	-2.4	-3.1 – -1.8
Balance Training	-0.9	-1.5 – -0.2

Baseline to 9 months

Group	Value	95% CI
Aerobic Training	-1.5	-2.2 – -0.8
Balance Training	-0.2	-0.84 – 0.5

Baseline to 12 months

Group	Value	95% CI
Aerobic Training	-1.4	-2.1 – -0.7
Balance Training	0	-0.66 – 0.70

Average Gait Speed Secondary · Baseline, 6 months, 9 months, 12 months

This is to measure average time to complete 8-meter walk test. Participants will walk 8 meters as fast as possible three different times. Gait will be reported as meters per second (m/s).

Baseline

Group	Value	95% CI
Aerobic Training	0.90	± 0.28
Balance Training	0.95	± 0.32

6 months

Group	Value	95% CI
Aerobic Training	0.80	± 0.26
Balance Training	0.89	± 0.30

9 months

Group	Value	95% CI
Aerobic Training	0.80	± 0.26
Balance Training	0.80	± 0.26

12 months

Group	Value	95% CI
Aerobic Training	0.80	± 0.26
Balance Training	0.79	± 0.26

Dynamic Gait Index Score Secondary · Baseline, 6 months, 9 months, 12 months

The dynamic gait index (DGI) will be performed to assess balance. Patients will be asked to walk 20 feet and conditions such as speed and head position will be varied as previously described. The examiner will then grade the subject's movement on a four-point ordinal scale, ranging from 0 (lowest level of function) to 3 (highest level of function). The total score range is 0 to 24, with higher scores indicating better dynamic balance and functional mobility.

Baseline

Group	Value	95% CI
Aerobic Training	11.8	± 2.0
Balance Training	11.7	± 2.0

6 months

Group	Value	95% CI
Aerobic Training	12.8	± 2.0
Balance Training	13.2	± 2.0

9 months

Group	Value	95% CI
Aerobic Training	13.0	± 2.0
Balance Training	13.2	± 2.0

12 months

Group	Value	95% CI
Aerobic Training	13.3	± 2.0
Balance Training	12.8	± 2.0

Timed Up and Go (TUG) Secondary · Baseline, 6 months, 9 months, 12 months

The Timed Up and Go will be performed to assess balance. Once the tester says "Go", participants will stand from seated and walk around a cone that is 3 meters away, then walk back to the chair and sit back down. Participants will be timed from the moment the tester says "Go" until seated again.

Baseline

Group	Value	95% CI
Aerobic Training	17.0	± 3.1
Balance Training	16.6	± 3.1

6 months

Group	Value	95% CI
Aerobic Training	15.5	± 3.1
Balance Training	15.7	± 3.1

9 months

Group	Value	95% CI
Aerobic Training	15.5	± 3.1
Balance Training	15.7	± 3.1

12 months

Group	Value	95% CI
Aerobic Training	16.8	± 3.1
Balance Training	16.7	± 3.1

Fatigue Severity Scale (FSS) Score Secondary · Baseline, 6 months, 9 months, 12 months

The FSS is a nine-item questionnaire that measures the severity of fatigue. Each item is rated on a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Scores for all nine items are summed to calculate the total score, which ranges from 9 to 63. Higher scores indicate greater fatigue severity.

Baseline

Group	Value	95% CI
Aerobic Training	41.2	± 5.1
Balance Training	33.5	± 5.2

6 months

Group	Value	95% CI
Aerobic Training	33.3	± 5.2
Balance Training	35.0	± 5.1

9 months

Group	Value	95% CI
Aerobic Training	35.6	± 5.2
Balance Training	34.8	± 5.2

12 months

Group	Value	95% CI
Aerobic Training	35.3	± 5.2
Balance Training	36.2	± 5.2

Quality of Life (QOL) - Physical Health Secondary · Baseline, 6 months, 9 months, 12 months

The WHOQOL-BREF measures self-perceived quality of life across four domains: Physical Health, Psychological, Social Relationships, and Environment. Scores are derived from a 5-point Likert scale, with higher scores indicating better quality of life in that specific area. To calculate the domain scores, the mean score for items within each domain is multiplied by 4, and these scores are transformed to a 0 - 100 scale for interpretation.

Baseline

Group	Value	95% CI
Aerobic Training	55.8	± 7.0
Balance Training	59.1	± 7.1

6 months

Group	Value	95% CI
Aerobic Training	54.3	± 7.1
Balance Training	60.1	± 7.1

9 months

Group	Value	95% CI
Aerobic Training	57.1	± 7.1
Balance Training	59.8	± 7.2

12 months

Group	Value	95% CI
Aerobic Training	57.1	± 7.1
Balance Training	60.7	± 7.2

Quality of Life (QOL) - Psychological Secondary · Baseline, 6 months, 9 months, 12 months

The WHOQOL-BREF measures self-perceived quality of life across four domains: Physical Health, Psychological, Social Relationships, and Environment. Scores are derived from a 5-point Likert scale, with higher scores indicating better quality of life in that specific area. To calculate the domain scores, the mean score for items within each domain is multiplied by 4, and these scores are transformed to a 0 - 100 scale for interpretation.

Baseline

Group	Value	95% CI
Aerobic Training	65.6	± 7.1
Balance Training	68.1	± 7.2

6 months

Group	Value	95% CI
Aerobic Training	63.1	± 7.2
Balance Training	67.6	± 7.2

9 months

Group	Value	95% CI
Aerobic Training	68.8	± 7.2
Balance Training	67.0	± 7.2

12 months

Group	Value	95% CI
Aerobic Training	66.2	± 7.2
Balance Training	66.2	± 7.2

Quality of Life (QOL) - Social Relationships Secondary · Baseline, 6 months, 9 months, 12 months

The WHOQOL-BREF measures self-perceived quality of life across four domains: Physical Health, Psychological, Social Relationships, and Environment. Scores are derived from a 5-point Likert scale, with higher scores indicating better quality of life in that specific area. To calculate the domain scores, the mean score for items within each domain is multiplied by 4, and these scores are transformed to a 0 - 100 scale for interpretation.

Baseline

Group	Value	95% CI
Aerobic Training	60.1	± 8.4
Balance Training	64.8	± 8.5

6 months

Group	Value	95% CI
Aerobic Training	65.5	± 8.4
Balance Training	53.0	± 8.4

9 months

Group	Value	95% CI
Aerobic Training	64.2	± 8.5
Balance Training	60.1	± 8.5

12 months

Group	Value	95% CI
Aerobic Training	65.4	± 8.6
Balance Training	65.7	± 8.5

Quality of Life (QOL) - Environment Secondary · Baseline, 6 months, 9 months, 12 months

The WHOQOL-BREF measures self-perceived quality of life across four domains: Physical Health, Psychological, Social Relationships, and Environment. Scores are derived from a 5-point Likert scale, with higher scores indicating better quality of life in that specific area. To calculate the domain scores, the mean score for items within each domain is multiplied by 4, and these scores are transformed to a 0 - 100 scale for interpretation.

Baseline

Group	Value	95% CI
Aerobic Training	65.5	± 5.7
Balance Training	68.3	± 5.7

6 months

Group	Value	95% CI
Aerobic Training	70.5	± 5.7
Balance Training	66.1	± 5.7

9 months

Group	Value	95% CI
Aerobic Training	69.5	± 5.7
Balance Training	69.6	± 5.7

12 months

Group	Value	95% CI
Aerobic Training	68.9	± 5.7
Balance Training	72.2	± 5.7

Adverse events — posted to ClinicalTrials.gov

Time frame: AE data was collected during in-person assessments at baseline, 6 months, 9 months, and 12 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Aerobic Training

Serious: 2/31 (6%)

Deaths: 0/31

Balance Training

Serious: 1/31 (3%)

Deaths: 0/31

Serious adverse events (2 terms)

Reaction	System	Aerobic Training	Balance Training
Car Accident, hospitalized	Social circumstances	—	—
Infection, hospitalized	Infections and infestations	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Aerobic Training	Balance Training
Falls	General disorders	—	—
Muscle Pain	Musculoskeletal and connective tissue disorders	—	—
Infection, not hospitalized	Infections and infestations	—	—
Fatigue	General disorders	—	—

Most-reported serious reactions: Car Accident, hospitalized, Infection, hospitalized.

Data from ClinicalTrials.gov NCT05002218 adverse events section.

Sponsor's own description

Balance and aerobic training show promise as treatments for degenerative cerebellar diseases, but the neural effects of both training methods are unknown. The goal of this project is to evaluate how each training method impacts the brain, and particularly, the degenerating cerebellum. Various neuroimaging techniques will be used to accomplish this goal and test the hypothesis that balance training impacts brain structures outside the cerebellum whereas aerobic training causes more neuroplastic changes within the cerebellum.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.