Trial Outcomes & Findings for Physical Therapy and Deep Brain Stimulation in Parkinson Disease (NCT NCT03181282)
NCT ID: NCT03181282
Last Updated: 2023-03-22
Results Overview
Number of participants with falls, orthopedic injuries, or other adverse events that are related to treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
8 weeks
Results posted on
2023-03-22
Participant Flow
31 participants provided informed consent and were enrolled in the study. 2 participants were unable to complete the baseline assessment and as such were not randomized. 29 participants were randomized to either the intervention or control group.
The expected enrollment planned for 34 participants due to expected attrition. Due to the lack of attrition, 29 participants were randomized in the study. This corresponds to the power analysis specifying a total sample size of 28 participants.
Participant milestones
| Measure |
Physical Therapy
Participants assigned to Physical Therapy (PT) will attend a 1-hour visit with a physical therapist twice weekly for 8 weeks. The PT intervention, which will mirror traditional PT for those with PD, will include exercises designed to improve balance and gait.
Physical Therapy: Postural stability exercises will follow a framework targeting quiet stance, anticipatory and reactive postural adjustments, and dynamic postural control. Gait exercises will include treadmill walking and practice with dual-task gait. A home exercise program (HEP), to be completed twice weekly, will be provided on each participant's initial visit with the physical therapist following STN-DBS surgery. The HEP will include the following exercises: trunk rotation, standing hip flexion, standing hip abduction, standing plantarflexion, and standing squat.
|
Control
Participants in the control group will receive the current standard of care following STN-DBS. As such, STN-DBS settings and anti-PD medications will be optimized according to the determination of their neurologist in the same fashion as they will be in the experimental group. Those in the control group will not receive prescribed exercise from a physical therapist.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Physical Therapy and Deep Brain Stimulation in Parkinson Disease
Baseline characteristics by cohort
| Measure |
Physical Therapy
n=15 Participants
Participants assigned to Physical Therapy (PT) will attend a 1-hour visit with a physical therapist twice weekly for 8 weeks. The PT intervention, which will mirror traditional PT for those with PD, will include exercises designed to improve balance and gait.
Physical Therapy: Postural stability exercises will follow a framework targeting quiet stance, anticipatory and reactive postural adjustments, and dynamic postural control. Gait exercises will include treadmill walking and practice with dual-task gait. A home exercise program (HEP), to be completed twice weekly, will be provided on each participant's initial visit with the physical therapist following STN-DBS surgery. The HEP will include the following exercises: trunk rotation, standing hip flexion, standing hip abduction, standing plantarflexion, and standing squat.
|
Control
n=14 Participants
Participants in the control group will receive the current standard of care following STN-DBS. As such, STN-DBS settings and anti-PD medications will be optimized according to the determination of their neurologist in the same fashion as they will be in the experimental group. Those in the control group will not receive prescribed exercise from a physical therapist.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
67.8 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
65.0 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Years Since PD Diagnosis
|
12.6 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
11.2 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
11.9 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Months Since STN-DBS
|
47.9 months
STANDARD_DEVIATION 31.2 • n=5 Participants
|
33.9 months
STANDARD_DEVIATION 27.2 • n=7 Participants
|
41.1 months
STANDARD_DEVIATION 29.7 • n=5 Participants
|
|
Mini-Mental Status Examination
|
28 scores on a scale
n=5 Participants
|
29 scores on a scale
n=7 Participants
|
29 scores on a scale
n=5 Participants
|
|
Movement Disorder Society-Unified Parkinson Disease Rating Scale - Section III (ON)
|
36 scores on a scale
STANDARD_DEVIATION 13.1 • n=5 Participants
|
30.2 scores on a scale
STANDARD_DEVIATION 8.7 • n=7 Participants
|
33.2 scores on a scale
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Movement Disorder Society-Unified Parkinson Disease Rating Scale - Section III (OFF)
|
52.1 scores on a scale
STANDARD_DEVIATION 11.2 • n=5 Participants
|
46.4 scores on a scale
STANDARD_DEVIATION 13.4 • n=7 Participants
|
49.4 scores on a scale
STANDARD_DEVIATION 12.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Because we are interested in potential adverse events related to the the intervention, we assessed only the PT group in this analysis.
Number of participants with falls, orthopedic injuries, or other adverse events that are related to treatment.
Outcome measures
| Measure |
Physical Therapy
n=14 Participants
Participants assigned to Physical Therapy (PT) will attend a 1-hour visit with a physical therapist twice weekly for 8 weeks. The PT intervention, which will mirror traditional PT for those with PD, will include exercises designed to improve balance and gait.
Physical Therapy: Postural stability exercises will follow a framework targeting quiet stance, anticipatory and reactive postural adjustments, and dynamic postural control. Gait exercises will include treadmill walking and practice with dual-task gait. A home exercise program (HEP), to be completed twice weekly, will be provided on each participant's initial visit with the physical therapist following STN-DBS surgery. The HEP will include the following exercises: trunk rotation, standing hip flexion, standing hip abduction, standing plantarflexion, and standing squat.
|
Control
Participants in the control group will receive the current standard of care following STN-DBS. As such, STN-DBS settings and anti-PD medications will be optimized according to the determination of their neurologist in the same fashion as they will be in the experimental group. Those in the control group will not receive prescribed exercise from a physical therapist.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events [Safety & Tolerability]
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: This variable is analyzed only for the PT group. Because the control group did not attend intervention sessions, this variable is not analyzed for this group.
Feasibility of the treatment as measured by the number of PT sessions attended.
Outcome measures
| Measure |
Physical Therapy
n=15 Participants
Participants assigned to Physical Therapy (PT) will attend a 1-hour visit with a physical therapist twice weekly for 8 weeks. The PT intervention, which will mirror traditional PT for those with PD, will include exercises designed to improve balance and gait.
Physical Therapy: Postural stability exercises will follow a framework targeting quiet stance, anticipatory and reactive postural adjustments, and dynamic postural control. Gait exercises will include treadmill walking and practice with dual-task gait. A home exercise program (HEP), to be completed twice weekly, will be provided on each participant's initial visit with the physical therapist following STN-DBS surgery. The HEP will include the following exercises: trunk rotation, standing hip flexion, standing hip abduction, standing plantarflexion, and standing squat.
|
Control
Participants in the control group will receive the current standard of care following STN-DBS. As such, STN-DBS settings and anti-PD medications will be optimized according to the determination of their neurologist in the same fashion as they will be in the experimental group. Those in the control group will not receive prescribed exercise from a physical therapist.
|
|---|---|---|
|
Treatment-Related Adherence [Feasibility]
|
15 Number of PT Sessions Attended
Interval 1.0 to 16.0
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: For the Off medication / Off stimulation condition, n=13 in the PT group and n=12 in the control group were analyzed. Those not analyzed did not complete this outcome measure at the post-test visit.
Change in Balance Evaluation Systems Test score. The scale is scored from 0-100% with higher scores indicating better balance. Here, the higher the change score, the greater the improvement in balance. A change score of 0.04 would correspond to a 4% improvement in the BESTest score. A change score of -0.02 would correspond to a 2% decline in BESTest score.
Outcome measures
| Measure |
Physical Therapy
n=14 Participants
Participants assigned to Physical Therapy (PT) will attend a 1-hour visit with a physical therapist twice weekly for 8 weeks. The PT intervention, which will mirror traditional PT for those with PD, will include exercises designed to improve balance and gait.
Physical Therapy: Postural stability exercises will follow a framework targeting quiet stance, anticipatory and reactive postural adjustments, and dynamic postural control. Gait exercises will include treadmill walking and practice with dual-task gait. A home exercise program (HEP), to be completed twice weekly, will be provided on each participant's initial visit with the physical therapist following STN-DBS surgery. The HEP will include the following exercises: trunk rotation, standing hip flexion, standing hip abduction, standing plantarflexion, and standing squat.
|
Control
n=14 Participants
Participants in the control group will receive the current standard of care following STN-DBS. As such, STN-DBS settings and anti-PD medications will be optimized according to the determination of their neurologist in the same fashion as they will be in the experimental group. Those in the control group will not receive prescribed exercise from a physical therapist.
|
|---|---|---|
|
Balance
On Medication / On Stimulation
|
0.04 Mean Change in BESTest Percent Score
Standard Deviation 0.04
|
-0.02 Mean Change in BESTest Percent Score
Standard Deviation 0.06
|
|
Balance
Off Medication / Off Stimulation
|
0.03 Mean Change in BESTest Percent Score
Standard Deviation 0.05
|
-0.04 Mean Change in BESTest Percent Score
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: For the Off medication / Off stimulation analysis, n=14 in the PT group and n=12 in the control group were analyzed. Those not analyzed did not complete this outcome measure at the post-test visit.
Change in gait velocity (cm/sec). Higher gait speeds are associated with better mobility. The greater the value for the change in gait speed, the greater the improvement in gait speed. Negative values would indicate a decline in gait speed.
Outcome measures
| Measure |
Physical Therapy
n=14 Participants
Participants assigned to Physical Therapy (PT) will attend a 1-hour visit with a physical therapist twice weekly for 8 weeks. The PT intervention, which will mirror traditional PT for those with PD, will include exercises designed to improve balance and gait.
Physical Therapy: Postural stability exercises will follow a framework targeting quiet stance, anticipatory and reactive postural adjustments, and dynamic postural control. Gait exercises will include treadmill walking and practice with dual-task gait. A home exercise program (HEP), to be completed twice weekly, will be provided on each participant's initial visit with the physical therapist following STN-DBS surgery. The HEP will include the following exercises: trunk rotation, standing hip flexion, standing hip abduction, standing plantarflexion, and standing squat.
|
Control
n=14 Participants
Participants in the control group will receive the current standard of care following STN-DBS. As such, STN-DBS settings and anti-PD medications will be optimized according to the determination of their neurologist in the same fashion as they will be in the experimental group. Those in the control group will not receive prescribed exercise from a physical therapist.
|
|---|---|---|
|
Gait
On Medication / On Stimulation
|
9.71 Change in Gait Velocity (Cm/Sec)
Standard Deviation 15.02
|
-1.07 Change in Gait Velocity (Cm/Sec)
Standard Deviation 10.5
|
|
Gait
Off Medication / Off Stimulation
|
7.29 Change in Gait Velocity (Cm/Sec)
Standard Deviation 12.84
|
-1.00 Change in Gait Velocity (Cm/Sec)
Standard Deviation 11.05
|
Adverse Events
Physical Therapy
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Control
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Physical Therapy
n=15 participants at risk
Participants assigned to Physical Therapy (PT) will attend a 1-hour visit with a physical therapist twice weekly for 8 weeks. The PT intervention, which will mirror traditional PT for those with PD, will include exercises designed to improve balance and gait.
Physical Therapy: Postural stability exercises will follow a framework targeting quiet stance, anticipatory and reactive postural adjustments, and dynamic postural control. Gait exercises will include treadmill walking and practice with dual-task gait. A home exercise program (HEP), to be completed twice weekly, will be provided on each participant's initial visit with the physical therapist following STN-DBS surgery. The HEP will include the following exercises: trunk rotation, standing hip flexion, standing hip abduction, standing plantarflexion, and standing squat.
|
Control
n=14 participants at risk
Participants in the control group will receive the current standard of care following STN-DBS. As such, STN-DBS settings and anti-PD medications will be optimized according to the determination of their neurologist in the same fashion as they will be in the experimental group. Those in the control group will not receive prescribed exercise from a physical therapist.
|
|---|---|---|
|
Cardiac disorders
Chest Pain
|
6.7%
1/15 • Number of events 1 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
14.3%
2/14 • Number of events 3 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
Other adverse events
| Measure |
Physical Therapy
n=15 participants at risk
Participants assigned to Physical Therapy (PT) will attend a 1-hour visit with a physical therapist twice weekly for 8 weeks. The PT intervention, which will mirror traditional PT for those with PD, will include exercises designed to improve balance and gait.
Physical Therapy: Postural stability exercises will follow a framework targeting quiet stance, anticipatory and reactive postural adjustments, and dynamic postural control. Gait exercises will include treadmill walking and practice with dual-task gait. A home exercise program (HEP), to be completed twice weekly, will be provided on each participant's initial visit with the physical therapist following STN-DBS surgery. The HEP will include the following exercises: trunk rotation, standing hip flexion, standing hip abduction, standing plantarflexion, and standing squat.
|
Control
n=14 participants at risk
Participants in the control group will receive the current standard of care following STN-DBS. As such, STN-DBS settings and anti-PD medications will be optimized according to the determination of their neurologist in the same fashion as they will be in the experimental group. Those in the control group will not receive prescribed exercise from a physical therapist.
|
|---|---|---|
|
Nervous system disorders
Fall
|
60.0%
9/15 • Number of events 35 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
64.3%
9/14 • Number of events 19 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Severe Joint Pain
|
53.3%
8/15 • Number of events 40 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
35.7%
5/14 • Number of events 15 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Persistent Muscle Soreness (> 2 days)
|
53.3%
8/15 • Number of events 21 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
42.9%
6/14 • Number of events 21 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
|
Nervous system disorders
Dizziness/Lightheaded
|
6.7%
1/15 • Number of events 1 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
28.6%
4/14 • Number of events 11 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
|
Nervous system disorders
Extreme Fatigue
|
0.00%
0/15 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
28.6%
4/14 • Number of events 10 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramping
|
6.7%
1/15 • Number of events 1 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
14.3%
2/14 • Number of events 2 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
|
Respiratory, thoracic and mediastinal disorders
Common Cold
|
0.00%
0/15 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
14.3%
2/14 • Number of events 2 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
|
Nervous system disorders
Anxiety Attack
|
6.7%
1/15 • Number of events 1 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
0.00%
0/14 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
|
Nervous system disorders
Headache
|
20.0%
3/15 • Number of events 3 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
7.1%
1/14 • Number of events 1 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain/Tightness
|
6.7%
1/15 • Number of events 1 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
0.00%
0/14 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Tooth Pain
|
0.00%
0/15 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
7.1%
1/14 • Number of events 2 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
0.00%
0/14 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Foot Soreness
|
6.7%
1/15 • Number of events 1 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
0.00%
0/14 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Shoulder Discomfort
|
0.00%
0/15 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
7.1%
1/14 • Number of events 1 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Bilateral Elbow Discomfort
|
0.00%
0/15 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
7.1%
1/14 • Number of events 1 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Tricep Nerve Pain
|
0.00%
0/15 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
7.1%
1/14 • Number of events 1 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
|
Eye disorders
Eye Infection
|
0.00%
0/15 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
7.1%
1/14 • Number of events 1 • The time frame of interest for adverse events was 8 weeks (after completion or pre-test and just prior to completion of post-test assessments).
Adverse events were collected weekly via phone interview using a custom questionnaire.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place