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Physical Therapy and Deep Brain Stimulation in Parkinson Disease
NA trial testing Physical Therapy in Parkinson Disease in 31 participants. Completed in 2 August 2019.
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 31 |
| Start date | 3 August 2017 |
| Primary completion | 2 August 2019 |
| Estimated completion | 2 August 2019 |
| Sites | 1 location across United States |
Washington University School of Medicine
30 and older, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participants with falls, orthopedic injuries, or other adverse events that are related to treatment.
| Group | Value | 95% CI |
|---|---|---|
| Physical Therapy | 1 |
Feasibility of the treatment as measured by the number of PT sessions attended.
| Group | Value | 95% CI |
|---|---|---|
| Physical Therapy | 15 | 1 – 16 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Physical Therapy | 0.04 | ± 0.04 |
| Control | -0.02 | ± 0.06 |
| Group | Value | 95% CI |
|---|---|---|
| Physical Therapy | 0.03 | ± 0.05 |
| Control | -0.04 | ± 0.07 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Physical Therapy | 9.71 | ± 15.02 |
| Control | -1.07 | ± 10.5 |
| Group | Value | 95% CI |
|---|---|---|
| Physical Therapy | 7.29 | ± 12.84 |
| Control | -1.00 | ± 11.05 |
Time frame: 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).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Physical Therapy | Control |
|---|---|---|---|
| Chest Pain | Cardiac disorders | — | — |
| Reaction | System | Physical Therapy | Control |
|---|---|---|---|
| Fall | Nervous system disorders | — | — |
| Severe Joint Pain | Musculoskeletal and connective tissue disorders | — | — |
| Persistent Muscle Soreness (> 2 days) | Musculoskeletal and connective tissue disorders | — | — |
| Dizziness/Lightheaded | Nervous system disorders | — | — |
| Extreme Fatigue | Nervous system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Muscle Cramping | Musculoskeletal and connective tissue disorders | — | — |
| Common Cold | Respiratory, thoracic and mediastinal disorders | — | — |
| Anxiety Attack | Nervous system disorders | — | — |
| Muscle Pain/Tightness | Musculoskeletal and connective tissue disorders | — | — |
| Tooth Pain | Musculoskeletal and connective tissue disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Foot Soreness | Musculoskeletal and connective tissue disorders | — | — |
| Shoulder Discomfort | Musculoskeletal and connective tissue disorders | — | — |
| Bilateral Elbow Discomfort | Musculoskeletal and connective tissue disorders | — | — |
| Tricep Nerve Pain | Musculoskeletal and connective tissue disorders | — | — |
| Eye Infection | Eye disorders | — | — |
Most-reported serious reactions: Chest Pain.
Data from ClinicalTrials.gov NCT03181282 adverse events section.
While deep brain stimulation of the subthalamic nucleus (STN-DBS) is commonly used to reduce tremor, muscle stiffness, and bradykinesia in people with Parkinson disease (PD), preliminary studies suggest balance may worsen and falls may increase after STN-DBS. Walking speed, known to be reduced in PD, typically improves after surgery; however, other important gait qualities may not improve. Given the potential for worsening balance and gait and increasing falls after surgery, it is imperative that researchers explore interventions that complement the positive effects of STN-DBS and delay worsening of balance and gait. Physical therapy (PT) is reported to be effective in improving balance and walking in people with PD. However, there have been no studies to investigate how individuals with STN-DBS respond to PT. As such, it is unclear if exercise in the post-DBS population is safe, feasible, and effective. The purpose of this study is to examine the safety, feasibility, and efficacy of PT in people with PD with STN-DBS. The investigators hypothesize that PT will be safe and feasible for people with PD with STN-DBS. Further, the investigators hypothesize that those assigned to PT group will demonstrate improvements in balance and gait while those assigned to the control group will demonstrate no change or a decline in balance and gait.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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