Trial Outcomes & Findings for Neuroplasticity in Parkinson´s Disease After Training (NCT NCT03213873)

NCT ID: NCT03213873

Last Updated: 2025-03-07

Results Overview

Mini-Balance Evaluation Systems Test a rating scale for dynamic balance incorporating 14 different balance and gait items that were assessed by a physical therapist on a scale from 0-2. Maximum points 28. 0-28 points with higher scores indicating better balance control

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 95 participants
• Primary outcome timeframe: Pre intervention baseline and post intervention at 10 weeks
• Results posted on: 2025-03-07

Participant Flow

Participant milestones

Measure	HiBalance The HiBalance program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in PD. The training will be conducted as a progressive individually adjusted group program in order to challenge the specific balance disorder of every participant and endorse progression. The intervention will be performed for an hour, 2 times/week in groups of six to eight participants for a total of 10 weeks and one home training session on their own. HiBalance: Intervention of highly challenging balance training for 10 weeks.	Speech Therapy The control group will receive a group treatment (2 times/w for 10 w + 1 home training session) consisting of speech and communication therapy performed by a speech therapist. This intervention will be performed in a sitting position. The speech and communication treatment will aim at increasing vocal loudness and improving articulatory precision. Level of difficulty is gradually increased by progressing from using loud voice and clear speech in short and automatized utterances, to using the same technique in more complex sentences and situations. The group format is used to practice techniques in communicative situations and also to introduce increasing level of multitasking by combining speech training with cognitively more challenging tasks in the group training. Speech and communication therapy: Intervention conducted by speech and language therapist for 10 weeks.
Overall Study STARTED	48	47
Overall Study COMPLETED	40	35
Overall Study NOT COMPLETED	8	12

Reasons for withdrawal

Measure	HiBalance The HiBalance program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in PD. The training will be conducted as a progressive individually adjusted group program in order to challenge the specific balance disorder of every participant and endorse progression. The intervention will be performed for an hour, 2 times/week in groups of six to eight participants for a total of 10 weeks and one home training session on their own. HiBalance: Intervention of highly challenging balance training for 10 weeks.	Speech Therapy The control group will receive a group treatment (2 times/w for 10 w + 1 home training session) consisting of speech and communication therapy performed by a speech therapist. This intervention will be performed in a sitting position. The speech and communication treatment will aim at increasing vocal loudness and improving articulatory precision. Level of difficulty is gradually increased by progressing from using loud voice and clear speech in short and automatized utterances, to using the same technique in more complex sentences and situations. The group format is used to practice techniques in communicative situations and also to introduce increasing level of multitasking by combining speech training with cognitively more challenging tasks in the group training. Speech and communication therapy: Intervention conducted by speech and language therapist for 10 weeks.
Overall Study Withdrawal by Subject	8	9
Overall Study Diagnosed w atypical PD after randomization	0	1
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	HiBalance n=48 Participants The HiBalance program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in PD. The training will be conducted as a progressive individually adjusted group program in order to challenge the specific balance disorder of every participant and endorse progression. The intervention will be performed for an hour, 2 times/week in groups of six to eight participants for a total of 10 weeks and one home training session on their own. HiBalance: Intervention of highly challenging balance training for 10 weeks.	Speech Therapy n=47 Participants The control group will receive a group treatment (2 times/w for 10 w + 1 home training session) consisting of speech and communication therapy performed by a speech therapist. This intervention will be performed in a sitting position. The speech and communication treatment will aim at increasing vocal loudness and improving articulatory precision. Level of difficulty is gradually increased by progressing from using loud voice and clear speech in short and automatized utterances, to using the same technique in more complex sentences and situations. The group format is used to practice techniques in communicative situations and also to introduce increasing level of multitasking by combining speech training with cognitively more challenging tasks in the group training. Speech and communication therapy: Intervention conducted by speech and language therapist for 10 weeks.	Total n=95 Participants Total of all reporting groups
Age, Continuous	71 years STANDARD_DEVIATION 5.9 • n=48 Participants	71.1 years STANDARD_DEVIATION 6.3 • n=47 Participants	71.1 years STANDARD_DEVIATION 6.1 • n=95 Participants
Sex: Female, Male Female	18 Participants n=48 Participants	17 Participants n=47 Participants	35 Participants n=95 Participants
Sex: Female, Male Male	30 Participants n=48 Participants	30 Participants n=47 Participants	60 Participants n=95 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Sweden	48 participants n=48 Participants	47 participants n=47 Participants	95 participants n=95 Participants
Disease stage Hoehn & Yahr Hoehn Yahr Stage 2	39 Participants n=48 Participants	34 Participants n=47 Participants	73 Participants n=95 Participants
Disease stage Hoehn & Yahr Hoehn Yahr Stage 3	9 Participants n=48 Participants	13 Participants n=47 Participants	22 Participants n=95 Participants

PRIMARY outcome

Timeframe: Pre intervention baseline and post intervention at 10 weeks

Population: All participants randomised included using intention-to-treat-analyses.

Mini-Balance Evaluation Systems Test a rating scale for dynamic balance incorporating 14 different balance and gait items that were assessed by a physical therapist on a scale from 0-2. Maximum points 28.

0-28 points with higher scores indicating better balance control

Outcome measures

Measure	HiBalance n=48 Participants The HiBalance program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in PD. The training will be conducted as a progressive individually adjusted group program in order to challenge the specific balance disorder of every participant and endorse progression. The intervention will be performed for an hour, 2 times/week in groups of six to eight participants for a total of 10 weeks and one home training session on their own. HiBalance: Intervention of highly challenging balance training for 10 weeks.	Speech Therapy n=47 Participants The control group will receive a group treatment (2 times/w for 10 w + 1 home training session) consisting of speech and communication therapy performed by a speech therapist. This intervention will be performed in a sitting position. The speech and communication treatment will aim at increasing vocal loudness and improving articulatory precision. Level of difficulty is gradually increased by progressing from using loud voice and clear speech in short and automatized utterances, to using the same technique in more complex sentences and situations. The group format is used to practice techniques in communicative situations and also to introduce increasing level of multitasking by combining speech training with cognitively more challenging tasks in the group training. Speech and communication therapy: Intervention conducted by speech and language therapist for 10 weeks.
Mini-BESTest Pre, observed values	20.7 score on a scale Standard Deviation 3.4	21.0 score on a scale Standard Deviation 3.5
Mini-BESTest Post, observed values	22.1 score on a scale Standard Deviation 3.0	21.8 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Pre intervention baseline and post intervention at 10 weeks

Population: All participants randomised were included using intention-to-treat analyses.

Gait speed in m/sec

Outcome measures

Measure	HiBalance n=48 Participants The HiBalance program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in PD. The training will be conducted as a progressive individually adjusted group program in order to challenge the specific balance disorder of every participant and endorse progression. The intervention will be performed for an hour, 2 times/week in groups of six to eight participants for a total of 10 weeks and one home training session on their own. HiBalance: Intervention of highly challenging balance training for 10 weeks.	Speech Therapy n=47 Participants The control group will receive a group treatment (2 times/w for 10 w + 1 home training session) consisting of speech and communication therapy performed by a speech therapist. This intervention will be performed in a sitting position. The speech and communication treatment will aim at increasing vocal loudness and improving articulatory precision. Level of difficulty is gradually increased by progressing from using loud voice and clear speech in short and automatized utterances, to using the same technique in more complex sentences and situations. The group format is used to practice techniques in communicative situations and also to introduce increasing level of multitasking by combining speech training with cognitively more challenging tasks in the group training. Speech and communication therapy: Intervention conducted by speech and language therapist for 10 weeks.
Gait Parameters Pre, observed values	1.2 m/sec Standard Deviation 0.2	1.2 m/sec Standard Deviation 0.2
Gait Parameters Post, observed values	1.3 m/sec Standard Deviation 0.2	1.2 m/sec Standard Deviation 0.2

SECONDARY outcome

Timeframe: Pre intervention baseline and post intervention at 10 weeks

Composite measure of executive functions of four tests:

1. letter fluency

2. the verbal fluency test: category switching

3. the colour-word interference test: switch condition (Test 1, 2 and 3 from the Delis-Kaplan Executive Function System)

4. the digit span total score (from Wechsler Adult Intelligence Scale)

First, the scores of each of the four tests were standardised into z-scores using pre-scores. Models using different test were compared. The model including all four tests and using the robust diagonally weighted least square estimation was chosen based on fit values. Factor loadings of the model: verbal fluency = 1.000, the verbal fluency test: category switching= 0.887, the colour-word interference test: switch condition= -0.855, the digit span total score= 0.813. Last, the z-scores of each test and person were multiplied with the factor loadings and added together to create a sum score for each person and time point. A higher value = greater executive functions

Outcome measures

Measure	HiBalance n=48 Participants The HiBalance program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in PD. The training will be conducted as a progressive individually adjusted group program in order to challenge the specific balance disorder of every participant and endorse progression. The intervention will be performed for an hour, 2 times/week in groups of six to eight participants for a total of 10 weeks and one home training session on their own. HiBalance: Intervention of highly challenging balance training for 10 weeks.	Speech Therapy n=47 Participants The control group will receive a group treatment (2 times/w for 10 w + 1 home training session) consisting of speech and communication therapy performed by a speech therapist. This intervention will be performed in a sitting position. The speech and communication treatment will aim at increasing vocal loudness and improving articulatory precision. Level of difficulty is gradually increased by progressing from using loud voice and clear speech in short and automatized utterances, to using the same technique in more complex sentences and situations. The group format is used to practice techniques in communicative situations and also to introduce increasing level of multitasking by combining speech training with cognitively more challenging tasks in the group training. Speech and communication therapy: Intervention conducted by speech and language therapist for 10 weeks.
Neuropsychological Tests Pre, observed values	0.6 z-scores Standard Deviation 2.6	-0.7 z-scores Standard Deviation 2.4
Neuropsychological Tests Post, observed values	1.5 z-scores Standard Deviation 2.6	0.1 z-scores Standard Deviation 3.0

SECONDARY outcome

Timeframe: Pre intervention baseline and post intervention at 10 weeks

The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communications and bodily discomfort).

The sum score is as a percentage score ranging between 0 and 100. Higher is better

Outcome measures

Measure	HiBalance n=48 Participants The HiBalance program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in PD. The training will be conducted as a progressive individually adjusted group program in order to challenge the specific balance disorder of every participant and endorse progression. The intervention will be performed for an hour, 2 times/week in groups of six to eight participants for a total of 10 weeks and one home training session on their own. HiBalance: Intervention of highly challenging balance training for 10 weeks.	Speech Therapy n=47 Participants The control group will receive a group treatment (2 times/w for 10 w + 1 home training session) consisting of speech and communication therapy performed by a speech therapist. This intervention will be performed in a sitting position. The speech and communication treatment will aim at increasing vocal loudness and improving articulatory precision. Level of difficulty is gradually increased by progressing from using loud voice and clear speech in short and automatized utterances, to using the same technique in more complex sentences and situations. The group format is used to practice techniques in communicative situations and also to introduce increasing level of multitasking by combining speech training with cognitively more challenging tasks in the group training. Speech and communication therapy: Intervention conducted by speech and language therapist for 10 weeks.
Quality of Life Questionnaires Pre, observed values	19.7 score on a scale Interval 13.1 to 30.9	17.8 score on a scale Interval 9.8 to 27.7
Quality of Life Questionnaires Post, observed values	17.5 score on a scale Interval 7.3 to 23.0	11.9 score on a scale Interval 7.3 to 25.4

SECONDARY outcome

Timeframe: Pre intervention baseline and post intervention at 10 weeks

Disease severity/symtoms in Parkinson's disease, Movement Disorder Society - Unified Parkinsons disease rating scale (MDS-UPDRS) Total score.

Higher score is worse, ranging from 0-272

Outcome measures

Measure	HiBalance n=48 Participants The HiBalance program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in PD. The training will be conducted as a progressive individually adjusted group program in order to challenge the specific balance disorder of every participant and endorse progression. The intervention will be performed for an hour, 2 times/week in groups of six to eight participants for a total of 10 weeks and one home training session on their own. HiBalance: Intervention of highly challenging balance training for 10 weeks.	Speech Therapy n=47 Participants The control group will receive a group treatment (2 times/w for 10 w + 1 home training session) consisting of speech and communication therapy performed by a speech therapist. This intervention will be performed in a sitting position. The speech and communication treatment will aim at increasing vocal loudness and improving articulatory precision. Level of difficulty is gradually increased by progressing from using loud voice and clear speech in short and automatized utterances, to using the same technique in more complex sentences and situations. The group format is used to practice techniques in communicative situations and also to introduce increasing level of multitasking by combining speech training with cognitively more challenging tasks in the group training. Speech and communication therapy: Intervention conducted by speech and language therapist for 10 weeks.
Movement Disorder Society - Unified Parkinsons Disease Rating Scale (MDS-UPDRS) Pre, observed values	51.0 score on a scale Standard Deviation 18.8	50.4 score on a scale Standard Deviation 15.5
Movement Disorder Society - Unified Parkinsons Disease Rating Scale (MDS-UPDRS) Post, observed values	48.2 score on a scale Standard Deviation 17.8	45.8 score on a scale Standard Deviation 16.8

SECONDARY outcome

Timeframe: Pre intervention baseline and post intervention at 10 weeks

Number of Steps per day.

Outcome measures

Measure	HiBalance n=48 Participants The HiBalance program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in PD. The training will be conducted as a progressive individually adjusted group program in order to challenge the specific balance disorder of every participant and endorse progression. The intervention will be performed for an hour, 2 times/week in groups of six to eight participants for a total of 10 weeks and one home training session on their own. HiBalance: Intervention of highly challenging balance training for 10 weeks.	Speech Therapy n=47 Participants The control group will receive a group treatment (2 times/w for 10 w + 1 home training session) consisting of speech and communication therapy performed by a speech therapist. This intervention will be performed in a sitting position. The speech and communication treatment will aim at increasing vocal loudness and improving articulatory precision. Level of difficulty is gradually increased by progressing from using loud voice and clear speech in short and automatized utterances, to using the same technique in more complex sentences and situations. The group format is used to practice techniques in communicative situations and also to introduce increasing level of multitasking by combining speech training with cognitively more challenging tasks in the group training. Speech and communication therapy: Intervention conducted by speech and language therapist for 10 weeks.
Physical Activity Measured With Accelerometers Pre, observed values	4936.6 steps per day Interval 3250.1 to 6798.9	5462.4 steps per day Interval 3094.6 to 7785.4
Physical Activity Measured With Accelerometers Post, observed values	4800.8 steps per day Interval 2839.1 to 6470.1	5609.5 steps per day Interval 4048.0 to 8628.9

SECONDARY outcome

Timeframe: Pre intervention baseline and post intervention at 10 weeks

Intervention dependent changes in brain structure i.e. gray matter volume measured as voxels Analyses defined as: were there any significant clusters of voxels explained by the interaction of group and time. In other words, were there significant changes in voxel activity that depended on the interventions when using a cluster-based threshold using group statistics..

Note that it is not possible to report this outcome per group. Additionally, MR statistics are not reported as measures of central tendency such as the mean or any alternatives provided.

Outcome measures

Measure	HiBalance n=34 Participants The HiBalance program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in PD. The training will be conducted as a progressive individually adjusted group program in order to challenge the specific balance disorder of every participant and endorse progression. The intervention will be performed for an hour, 2 times/week in groups of six to eight participants for a total of 10 weeks and one home training session on their own. HiBalance: Intervention of highly challenging balance training for 10 weeks.	Speech Therapy n=31 Participants The control group will receive a group treatment (2 times/w for 10 w + 1 home training session) consisting of speech and communication therapy performed by a speech therapist. This intervention will be performed in a sitting position. The speech and communication treatment will aim at increasing vocal loudness and improving articulatory precision. Level of difficulty is gradually increased by progressing from using loud voice and clear speech in short and automatized utterances, to using the same technique in more complex sentences and situations. The group format is used to practice techniques in communicative situations and also to introduce increasing level of multitasking by combining speech training with cognitively more challenging tasks in the group training. Speech and communication therapy: Intervention conducted by speech and language therapist for 10 weeks.
Structural Magnetic Resonance Imaging	0 Significant clusters of voxels	0 Significant clusters of voxels

SECONDARY outcome

Timeframe: Pre intervention baseline and post intervention at 10 weeks

Population: All participants without missing or too low-quality fMRI data were included

Intervention dependent changes in task-induced brain activity, voxel-wise analyses of whole brain. (Name of the task performed during fMRI; the serial reaction time task.)

Analyses defined as: were there any significant clusters of voxels explained by the interaction of group and time. In other words, were there significant changes in voxel activity that depended on the interventions when using a cluster-based threshold. The measure type number was chosen because we estimated the number of significant clusters of voxels. Group statistics were perfromed

Note that for task fMRI interaction analyses, there are no meaningful values to report for the groups respectively.

Outcome measures

Measure	HiBalance n=32 Participants The HiBalance program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in PD. The training will be conducted as a progressive individually adjusted group program in order to challenge the specific balance disorder of every participant and endorse progression. The intervention will be performed for an hour, 2 times/week in groups of six to eight participants for a total of 10 weeks and one home training session on their own. HiBalance: Intervention of highly challenging balance training for 10 weeks.	Speech Therapy n=28 Participants The control group will receive a group treatment (2 times/w for 10 w + 1 home training session) consisting of speech and communication therapy performed by a speech therapist. This intervention will be performed in a sitting position. The speech and communication treatment will aim at increasing vocal loudness and improving articulatory precision. Level of difficulty is gradually increased by progressing from using loud voice and clear speech in short and automatized utterances, to using the same technique in more complex sentences and situations. The group format is used to practice techniques in communicative situations and also to introduce increasing level of multitasking by combining speech training with cognitively more challenging tasks in the group training. Speech and communication therapy: Intervention conducted by speech and language therapist for 10 weeks.
Task-induced Brain Activity as Measured by Functional Magnetic Resonance Imaging	0 significant clusters of voxels	0 significant clusters of voxels

SECONDARY outcome

Timeframe: Pre intervention baseline and post intervention at 10 weeks

Mature Brain-derived neurotrophic factor (mBDNF) in serum

Outcome measures

Measure	HiBalance n=48 Participants The HiBalance program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in PD. The training will be conducted as a progressive individually adjusted group program in order to challenge the specific balance disorder of every participant and endorse progression. The intervention will be performed for an hour, 2 times/week in groups of six to eight participants for a total of 10 weeks and one home training session on their own. HiBalance: Intervention of highly challenging balance training for 10 weeks.	Speech Therapy n=47 Participants The control group will receive a group treatment (2 times/w for 10 w + 1 home training session) consisting of speech and communication therapy performed by a speech therapist. This intervention will be performed in a sitting position. The speech and communication treatment will aim at increasing vocal loudness and improving articulatory precision. Level of difficulty is gradually increased by progressing from using loud voice and clear speech in short and automatized utterances, to using the same technique in more complex sentences and situations. The group format is used to practice techniques in communicative situations and also to introduce increasing level of multitasking by combining speech training with cognitively more challenging tasks in the group training. Speech and communication therapy: Intervention conducted by speech and language therapist for 10 weeks.
Wet Biomarkers Pre, observed values	38010.8 pg/mL Standard Deviation 7956.7	37805.3 pg/mL Standard Deviation 5928.3
Wet Biomarkers Post, observed values	37169.4 pg/mL Standard Deviation 8044.6	35945.8 pg/mL Standard Deviation 6208.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre intervention baseline

Population: This variable were never analysed pre and post since it is not sensitive in patients with mild dysarthria. The variable was just used for describing the group.

The Dysarthria Assessment also includes the Questionnaire on Acquired Speech Disorders (QASD, Swedish: Självsvarsformulär om Förvärvade Talstörningar) which is a self-report instrument that captures the subjective symptoms and experiences of individuals living with acquired speech disorders. Three subscales are included: "My Speech and Language", "Speech and Language in Social Interaction", and "Personal and Environmental Factors". Each item is rated on a four-point scale from 0 (definitely false) to 3 (definitely true), with higher scores indicating more severe symptoms. The overall QASD score was determined by calculating the average score of all sub-scales.

Outcome measures

Measure	HiBalance n=47 Participants The HiBalance program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in PD. The training will be conducted as a progressive individually adjusted group program in order to challenge the specific balance disorder of every participant and endorse progression. The intervention will be performed for an hour, 2 times/week in groups of six to eight participants for a total of 10 weeks and one home training session on their own. HiBalance: Intervention of highly challenging balance training for 10 weeks.	Speech Therapy n=43 Participants The control group will receive a group treatment (2 times/w for 10 w + 1 home training session) consisting of speech and communication therapy performed by a speech therapist. This intervention will be performed in a sitting position. The speech and communication treatment will aim at increasing vocal loudness and improving articulatory precision. Level of difficulty is gradually increased by progressing from using loud voice and clear speech in short and automatized utterances, to using the same technique in more complex sentences and situations. The group format is used to practice techniques in communicative situations and also to introduce increasing level of multitasking by combining speech training with cognitively more challenging tasks in the group training. Speech and communication therapy: Intervention conducted by speech and language therapist for 10 weeks.
Dysarthria	0.66 score on a scale Standard Deviation 0.44	0.43 score on a scale Standard Deviation 0.35

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre intervention baseline and post intervention at 10 weeks

The recordings were performed according to standardised routines for high-quality recordings in a sound-proof recording studio with the equipment Sony Digital Audio Tape Deck DTC-ZE700 and the software Sopran (version 1.0.22 © Tolvan Data). Measures were performed by a speech and language pathologist.

The outcome measure from the studio recordings used in the present study was mean voice sound level (dB SPL) in reading a Swedish standardised text.

Outcome measures

Measure	HiBalance n=48 Participants The HiBalance program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in PD. The training will be conducted as a progressive individually adjusted group program in order to challenge the specific balance disorder of every participant and endorse progression. The intervention will be performed for an hour, 2 times/week in groups of six to eight participants for a total of 10 weeks and one home training session on their own. HiBalance: Intervention of highly challenging balance training for 10 weeks.	Speech Therapy n=47 Participants The control group will receive a group treatment (2 times/w for 10 w + 1 home training session) consisting of speech and communication therapy performed by a speech therapist. This intervention will be performed in a sitting position. The speech and communication treatment will aim at increasing vocal loudness and improving articulatory precision. Level of difficulty is gradually increased by progressing from using loud voice and clear speech in short and automatized utterances, to using the same technique in more complex sentences and situations. The group format is used to practice techniques in communicative situations and also to introduce increasing level of multitasking by combining speech training with cognitively more challenging tasks in the group training. Speech and communication therapy: Intervention conducted by speech and language therapist for 10 weeks.
Voice Strength Pre, observed values	70.3 dB Standard Deviation 3.5	70.8 dB Standard Deviation 4.0
Voice Strength Post, observed values	70.6 dB Standard Deviation 3.9	73.0 dB Standard Deviation 4.0

Adverse Events

HiBalance

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Speech Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	HiBalance n=48 participants at risk The HiBalance program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in PD. The training will be conducted as a progressive individually adjusted group program in order to challenge the specific balance disorder of every participant and endorse progression. The intervention will be performed for an hour, 2 times/week in groups of six to eight participants for a total of 10 weeks and one home training session on their own. HiBalance: Intervention of highly challenging balance training for 10 weeks.	Speech Therapy n=47 participants at risk The control group will receive a group treatment (2 times/w for 10 w + 1 home training session) consisting of speech and communication therapy performed by a speech therapist. This intervention will be performed in a sitting position. The speech and communication treatment will aim at increasing vocal loudness and improving articulatory precision. Level of difficulty is gradually increased by progressing from using loud voice and clear speech in short and automatized utterances, to using the same technique in more complex sentences and situations. The group format is used to practice techniques in communicative situations and also to introduce increasing level of multitasking by combining speech training with cognitively more challenging tasks in the group training. Speech and communication therapy: Intervention conducted by speech and language therapist for 10 weeks.
Musculoskeletal and connective tissue disorders Non-injurious falls	14.6% 7/48 • During the 10 weeks of the interventions.	0.00% 0/47 • During the 10 weeks of the interventions.
Musculoskeletal and connective tissue disorders Calf-muscle strain	2.1% 1/48 • During the 10 weeks of the interventions.	0.00% 0/47 • During the 10 weeks of the interventions.

Additional Information

Erika Franzén

Karolinska Institutet

Phone: 08-52488878

Email: erika.franzen@ki.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place