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Due to Parkinson's Disease (PD) speech and language (SL) deficits may occur. Further, the literature reports that PD patients, who have not undergone deep brain stimulation (DBS), have deficits regarding voice quality (e.g. loudness and intelligibility of their voice), while PD patients who have undergone DBS suffer from deficits in word retrieval and speech apraxia symptoms. To-date, therapeutic approaches focusing specifically on SL deficits observed in PD-DBS patients are yet to be developed and evaluated.
Therefore, this study investigates the short-and longterm effectiveness of specific and intensive, high-frequency speech-language therapy in terms of reducing SL-deficits compared to a nonspecific and non-verbal sham treatment (i.e. a rhythmic balance-movement training (rBMT)) as well as to a 'no-therapy' condition.
In the course of Parkinson's disease (PD) speech and language (SL) deficits may often emerge. In addition, severe verbal fluency (VF) decline has been repeatedly observed in the context of deep brain stimulation (DBS) in PD. Interestingly, while PD non-DBS patients have deficits with respect to loudness and intelligibility of their voice, PD patients who have undergone DBS (PD-DBS) suffer rather from difficulties in semantic and phonemic word retrieval, and from speech apraxia symptoms.
However, to-date and to the best of our knowledge, therapeutic approaches focusing specifically on SL deficits observed in PD-DBS patients are yet to be developed and evaluated regarding their effectiveness. Thus, this study investigates the short-and longterm effectiveness of specific and intensive, high-frequency speech-language therapy in terms of reducing SL-deficits compared to a nonspecific and non-verbal sham treatment (i.e. a rhythmic balance-movement training (rBMT)) as well as to a 'no-therapy' condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specific SL-therapy for PD (with and without DBS) | Experimental | Rhythmic specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks |
|
| rBMT for PD (with and without DBS) | Active Comparator | Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks |
|
| PD (with and without DBS); no therapy | No Intervention | No further recruiting necessary, as data is already at hand via previous research projects. | |
| Healthy Controls; no therapy | No Intervention | No further recruiting necessary, as data is already at hand via previous research projects. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specific SL-therapy | Other | Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total. |
| Measure | Description | Time Frame |
|---|---|---|
| Velocity in Gait | Gait Velocity: meters per second | At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M). |
| Cadence in Gait | 4-Weeks and 6-Months Follow-up. To measure rhythmicity in gait, participants walked 6 metres at their individual pace. They were timed and amount of steps were counted. | At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M). |
| Speech Velocity | Speech Velocity at 4 weeks and at 6 months To measure rhythmicity in speech, participants read a text aloud ('the north wind and the sun') and were recorded using an Olympus. According to these speech samples, the count of elicited syllables per second was calculated. | At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M). |
| Speech Cadence | Speech Cadence 4 Weeks and at 6 Months To measure rhythmicity in speech, participants' speech was recorded while reading a text aloud ('the north wind and the sun'). Elicited syllables per inspiration were analysed. | At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M). |
| Measure | Description | Time Frame |
|---|---|---|
| Health Status (UPDRS) | The complete questionnaire 'Unified Parkinson's Disease Rating Scale' (UPDRS) was filled out at BL and 6M. Scores may range from 0-4 per question. Final scores may add up to 199 points maximum. The higher the score, the worse disease severity/ degree of disability is. | At Baseline and 6 Months |
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Inclusion Criteria for all groups:
Specific Inclusion Criteria for the DBS Group
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Fuhr, Prof.Dr.med. | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | Canton of Basel-City | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34808624 | Derived | Roesch AD, Gschwandtner U, Handabaka I, Meyer A, Taub E, Fuhr P. Effects of Rhythmic Interventions on Cognitive Abilities in Parkinson's Disease. Dement Geriatr Cogn Disord. 2021;50(4):372-386. doi: 10.1159/000519122. Epub 2021 Oct 28. |
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Eligibility assessments were conducted by neurologists, neuropsychologists and speech-language therapists. Eligibility criteria led to 12 exclusions in the PD group and to 4 exclusions in the HC group.
Therefore, final N count for the study were: N=20 PD patients and N=18 HC.
From May 2015 to February 2018, N=32 patients with idiopathic Parkinson's disease (PD) were recruited from the University Hospital Basel (Switzerland) and N=22 healthy controls (HC) were recruited from senior health centers or sports groups independent of the hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | rSLT, Then no Therapy, Then rBMT | Specific, intensive and high-frequency speech-language-therapy (rSLT). Approx. 45 Min. per session, 3 times per week for 4 weeks Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total. Please note: this was a case-crossover study. Participants, who completed the above stated and described intervention, had then the opportunity to switch to the 'no therapy' group. After having completed the 6 months 'no therapy' period, the participant could enrol again into the 'rhythmic balance-movement training'' rBMT). |
| FG001 | rBMT, Then 'no Therapy', Then rSLT | Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total. Please note: this was a case-crossover study. Participants, who completed the above stated and described intervention, had then the opportunity to switch to the 'no therapy' group. After having completed the 6-months period as 'no therapy', the participant could switch to the 'rhythmic speech-language therapy' group (rSLT). |
| FG002 | No Therapy, Then rSLT, Then rBMT | "the 6-months-waiting list". Patients with Parkinson's disease (PD) who had to wait for/ or chose to receive treatments at a later time. Please note: this was a case-crossover study. After completing the 6-month waiting list (no therapy), participants had then the opportunity to switch to another study arm (being 'rhythmic speech-language therapy' (rSLT) or 'rhythmic balance-movement training' (rBMT). After having completed the second intervention program, the participant could enrol again into a study arm, which he/she has not been before (i.e. either 'rhythmic speech-language therapy' (rSLT) or 'rhythmic balance-movement training'' rBMT). |
| FG003 | Healthy Controls; no Therapy | Healthy Controls received no therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Testing and Therapy Period 1 |
| |||||||||||||
| Testing and Therapy Period 2 |
| |||||||||||||
| Testing and Therapy Period 3 |
|
In this cross-over study, there were 20 PD patients and 18 healthy controls enrolled (HC final N=17, because on participant was lost to Follow-up).This baseline analysis gives all information per group, and PD patients could switch between the different groups (i.e. rSLT, rBMT, NT).
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| ID | Title | Description |
|---|---|---|
| BG000 | rSLT, Then no Therapy, Then rBMT | Specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total. Then participants could be allocated to the no-therapy group, and after 6-month completion again into the rBMT intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Velocity in Gait | Gait Velocity: meters per second | Posted | Mean | Standard Deviation | meter per second | At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M). |
|
Adverse Events were collected over the full length of the study for each participant. Beginning at the baseline measurement up to 1 year after completion.
This cross-over study involved non-invasive intensive treatments (i.e. rhythmic speech therapy vs. rhythmic balance-mobility training).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Specific SL-therapy for PD-DBS and Non-DBS | Specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks Specific SL-therapy: Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Peter Fuhr | University Hospital Basel | 0041 61 265 | 41 66 | peter.fuhr@usb.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2019 | Oct 28, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D004401 | Dysarthria |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| Rhythmic Balance-Movement Training (rBMT) | Other | Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total. |
|
| Neuropsychiatric Self-rating Questionnaires |
Self-rating questionnaires investigating depression using the Beck's Depression Inventory (BDI). This is a 21 question, multiple choice, self-report questionnaire. Minimum score is 0 and maximum scores is 63. The higher the score the more severe is the depression. Details: 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. |
| At 4 Weeks and 6 Months |
| Neuropsychological Standardised Test Battery | Inhibition Control (Stroop), Visio-Construction (Mosaic), Flexibility (Trail Making Test), Episodic Memory (Basel Verbal Learning Test -long delayed free recall), Working Memory (backwards digit span task by Wechsler). Scores were standardized (z-scores) to a mean of 0 and standard deviation of 1. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population | At 4 Weeks and at 6 Months |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | rBMT, Then rSLT, Then no Therapy | Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total. Then participants could be enrolled in the rSLT group, and after 6-month completion again into the 'no-therapy' group. |
| BG002 | No Therapy, Then rSLT or rBMT, Then rBMT or rSLT | "the 6-months-waiting list". PD patients who had to wait for/ or chose to receive treatments at a later time. After 6-month completion, participants could enrol in the rSLT or the rBMT intervention program, and then upon 6-month completion again in the opposite intervention program, being rBMT or rSLT, respectively. |
| BG003 | Healthy Controls; no Therapy | Healthy Controls received no therapy. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Speech Velocity | Mean | Standard Deviation | spoken syllables per second |
|
| Speech Cadence | Mean | Standard Deviation | Spoken syllables per inspiration |
|
| Gait velocity | Mean | Standard Deviation | meters per second |
|
| Gait Cadence | Mean | Standard Deviation | steps per second |
|
| OG002 | PD-DBS/ Non-DBS; no Therapy | "the 6-months-waiting list". PD patients who had to wait for/ or chose to receive treatments at a later time. |
| OG003 | Healthy Controls; no Therapy | Healthy Controls received no therapy. |
|
|
|
| Primary | Cadence in Gait | 4-Weeks and 6-Months Follow-up. To measure rhythmicity in gait, participants walked 6 metres at their individual pace. They were timed and amount of steps were counted. | Posted | Mean | Standard Deviation | steps per second | At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M). |
|
|
|
| Primary | Speech Velocity | Speech Velocity at 4 weeks and at 6 months To measure rhythmicity in speech, participants read a text aloud ('the north wind and the sun') and were recorded using an Olympus. According to these speech samples, the count of elicited syllables per second was calculated. | Posted | Mean | Standard Deviation | spoken syllables per second | At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M). |
|
|
|
| Primary | Speech Cadence | Speech Cadence 4 Weeks and at 6 Months To measure rhythmicity in speech, participants' speech was recorded while reading a text aloud ('the north wind and the sun'). Elicited syllables per inspiration were analysed. | Posted | Mean | Standard Deviation | spoken syllables per inspiration | At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M). |
|
|
|
| Secondary | Health Status (UPDRS) | The complete questionnaire 'Unified Parkinson's Disease Rating Scale' (UPDRS) was filled out at BL and 6M. Scores may range from 0-4 per question. Final scores may add up to 199 points maximum. The higher the score, the worse disease severity/ degree of disability is. | Posted | Mean | Standard Deviation | score on a scale | At Baseline and 6 Months |
|
|
|
|
| Secondary | Neuropsychiatric Self-rating Questionnaires | Self-rating questionnaires investigating depression using the Beck's Depression Inventory (BDI). This is a 21 question, multiple choice, self-report questionnaire. Minimum score is 0 and maximum scores is 63. The higher the score the more severe is the depression. Details: 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. | Posted | Mean | Standard Deviation | score | At 4 Weeks and 6 Months |
|
|
|
| Secondary | Neuropsychological Standardised Test Battery | Inhibition Control (Stroop), Visio-Construction (Mosaic), Flexibility (Trail Making Test), Episodic Memory (Basel Verbal Learning Test -long delayed free recall), Working Memory (backwards digit span task by Wechsler). Scores were standardized (z-scores) to a mean of 0 and standard deviation of 1. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population | Posted | Mean | Standard Deviation | z-scores | At 4 Weeks and at 6 Months |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | rBMT for PD-DBS and Non-DBS | Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks Rhythmic Balance-Movement Training (rBMT): Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total. | 1 | 20 | 0 | 20 | 0 | 20 |
| EG002 | PD-DBS/ Non-DBS; no Therapy | "the 6-months-waiting list". PD patients who had to wait for/ or chose to receive treatments at a later time. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG003 | Healthy Controls; no Therapy | Healthy Controls received no therapy. | 0 | 18 | 0 | 18 | 0 | 18 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001184 | Articulation Disorders |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|
| Gait Cadence-6M |
|
| Speech velocity 6M |
|
| Speech Cadence 6M |
|
| UPDRS-6M |
|
| BDI-6M |
|
| Episodic Memory-6M |
|
| Working Memory-4W |
|
| Working Memory-6M |
|
| Visuo-Construction-4W |
|
| Visa-Construction-6M |
|
| Inhibition (Stroop)-4W |
|
| Inhibition (Stroop)-6M |
|
| Flexibility (TMT)-4W |
|
| Flexibility (TMT)-6M |
|