Parkinson DiseaseBETA-PDNCT02727478
Effectiveness and Implementation of the HiBalance Program in Clinical Practice
A study testing HiBalance training program in people with Parkinson Disease, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This effectiveness-implementation study is a part of the larger study BETA-PD (Balance, Elderly, Training and Activity in Parkinson's Disease), which has the long-term goal to reduce the risk of falling in people with Parkinson's disease (PD) by improving balance, gait and physical activity level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- HiBalance training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteSweden
- Study dates
- 28 Mar 2016to 28 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed idiopathic Parkinson's Disease
- Measured balance impairment (according to the mini-BESTest)
- Hoehn and Yahr stages 2-3
- Independent ambulator indoors without a walking aid
Who cannot join
- Cognitive impairment which hinders participation in group training
- The presence of comorbidities which hinder safe participation in group training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Highly Challenging Balance Training for People With Parkinson's Disease (the BETA-PD Study): Non-randomized Hybrid Effectiveness-implementation Trial
This effectiveness-implementation study is a part of the larger study BETA-PD (Balance, Elderly, Training and Activity in Parkinson's Disease), which has the long-term goal to reduce the risk of falling in people with Parkinson's disease (PD) by improving balance, gait and physical activity level. The main hypothesis is that highly challenging balance training will lead to greater gait and balance ability, increased levels of physical activity and an improved health related quality of life. The main aims of the study are to evaluate the effectiveness of the HiBalance program in real-life clinical settings, while exploring facilitators and barriers for program implementation on a wider scale.
Read the detailed description
The clinical features of PD include progressive postural instability, hypokinesia, tremor and rigidity. It is therefore common that people with PD experience reduced balance and gait function, symptoms which can have far-reaching negative effects on their health and quality of life. Injurious falls and fear of falling are especially prevalent among those with PD, a factor which may partly explain why this group are less physically active than older people of a similar age without the diagnosis. Balance and gait training, on the other hand, have been shown effective in PD and also appear to have potential neuro-protective properties. Research in the area of balance training in PD disease however is sparse and previous interventions have been criticized for applying training stimuli which lacked intensity and challenge.
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 program was developed to affect symptom-specific balance impairments in PD by targeting four main subsystems underlying balance control (stability limits, anticipatory postural adjustments, sensory integration and motor agility). The intervention consists of a 10-week progressive balance training program in group format (5-7 participants). Each training session is conducted by a minimum of 2 physiotherapist trainers, during twice weekly 1-hour sessions (20 hours in total). Additionally, a home-exercise program is carried out by the participants once a week during the trial period. The difficulty level of the group-based training is increased in three consecutive blocks. To ensure highly challenging exercises, each task is individually adjusted by altering the area of base of support, increasing movement speed/amplitude and/or restricting vision and varying the grade of multitasking. The program has previously been proven feasible [Conradsson, 2012] and effective [Conradsson, 2015] in improving balance and gait impairments in a randomized controlled hospital setting. In addition, favorable transfer effects were seen in relation to physical activity levels and the performance of activities of everyday life.
For research interventions to be adopted in real-life clinical settings however a level of adaptation is required. Best practice then involves evaluating the effectiveness of efficacious programs in clinical settings, in order to verify whether or not the adaptation has attenuated the effective core elements of the program itself.
The current study combines a clinical effectiveness trial together with implementation research. Use of a type-1 hybrid design will allow the effects of the HiBalance program in clinical settings to be tested while simultaneously gathering information on barriers and facilitators to the implementation process [Curran, 2012]. Use of the hybrid design also allows for constant monitoring of the process by which the intervention is applied, and therefore allow problems in early application to be identified and quickly altered so as to ensure better outcomes. A participatory approach will be adhered to whereby 'users' of the program (physiotherapist trainers) will be actively involved in all stages of the program adaptation, process and outcome evaluation. This approach is recommended in order to increase the relevance, acceptability and successful implementation of the program. The Consolidated Framework for Implementation Research (CFIR) will be used in the current study to guide the investigation of potential barriers to and facilitators of the implementation process [Damschroder, 2009 ].
- Conditions
- Parkinson Disease
- Being tested
- HiBalance training program
- Keywords
- Balance, Rehabilitation, Exercise, basal ganglia, Gait, Training, physical activity
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiBalance training programOther
The program consists of physiotherapist led highly challenging balance exercises, which are adapted and progressed on both a group and individual basis throughout the training period.
| Study group | Role | What they receive |
|---|---|---|
| Balance training group | Experimental | 1 hour group balance training twice weekly for 10 weeks, as well as perform a home exercise program. Receives: Other: HiBalance training program |
| Control group | No intervention | Subjects in this group will receive no intervention and will be advised to continue their normal level of exercise throughout the intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mini-BESTest Score From Baseline at 1 Week Post Intervention.
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 The mini-BESTest is an assessment of balance performance and will be performed by the physiotherapists in the respective clinics.
Measured: Change in Mini-BESTest score from baseline at 1 week post intervention.
Secondary outcomes (6)
Change in 10-meter Walking Test Score From Baseline at 1 Week Post Intervention.
The 10-meter walking test assesses gait performance was performed by the physiotherapists in the respective clinics.
Gait speed was measured as m/sec during 10 meters
Measured: From baseline at 1 week post intervention.
Change in Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention.
The TUG test assesses functional mobility and will be performed by the physiotherapists in the respective clinics. TUG test measures performance of a sequential locomotor task (rising from a chair, walking 3 m, turning and walking back to the chair). Timed Up and Go (TUG) test is measured in seconds it takes to perform the task.
Measured: From baseline at 1 week post intervention.
Change in EQ-5D Score From Baseline at 1week Post Intervention.
The EQ-5D is a 2-paged form assessing health-related quality of life and will be filled in by participants.
European Quality of Life- 5 dimensions (EQ-5D), The visual analogue scale (VAS) indicates the general health status ranging from 0-100 with 100 indicating the best health status
Measured: From baseline at 1week post intervention.
Change in Activities-specific Balance Confidence (ABC) Scale
The ABC scale assesses self-reported balance confidence and will be filled in by study participants.
It consists of 16 items that are rated from from 0-100% where 0% indicates no confidence and 100% complete confidence.
The overall score is calculated by adding the item scores and dividing the total by 16 (i.e. the number of items). This total score ranges from 0% to 100%.
Measured: From baseline at 1 week post intervention.
Change in Physical Activity Level From Baseline 1 Week Post Intervention.
Participants will wear accelerometers for a 7-day period directly before and after the intervention.
Physical activity level (steps per day)
Measured: from baseline to 1 week post intervention
Change in Dual Task Interference During the Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention.
The TUG test assesses functional mobility and will be performed by the physiotherapists in the respective clinics.
TUG test measures performance of a sequential locomotor task (rising from a chair, walking 3 m, turning and walking back to the chair).The TUG COG test involves performance of the TUG test while sequentially subtracting the number 3 from a start number. The time difference between the TUG and the TUG COG reflects dual-task interference during functional mobility and is calculated be expressed as a percentage: (TUG COG - TUG)/TUG.
Measured: From baseline at 1 week post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study start28 Mar 2016
- Primary completion20 Feb 2018
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Erika Franzén, Karolinska Institutet
- Investigators
- Erika Franzén, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727478
- Sponsor's protocol ID
- 2016/210-31/2
- Acronym
- BETA-PD
- Status last verified
- Aug 2023
- First submitted
- 22 Mar 2016
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Conradsson D, Lofgren N, Stahle A, Hagstromer M, Franzen E. A novel conceptual framework for balance training in Parkinson's disease-study protocol for a randomised controlled trial. BMC Neurol. 2012 Sep 27;12:111. doi: 10.1186/1471-2377-12-111.
PubMed 23017069Conradsson D, Lofgren N, Nero H, Hagstromer M, Stahle A, Lokk J, Franzen E. The Effects of Highly Challenging Balance Training in Elderly With Parkinson's Disease: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2015 Oct;29(9):827-36. doi: 10.1177/1545968314567150. Epub 2015 Jan 21.
PubMed 25608520Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
PubMed 22310560Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
PubMed 19664226Leavy B, Joseph C, Lofgren N, Johansson H, Hagstromer M, Franzen E. Outcome Evaluation of Highly Challenging Balance Training for People With Parkinson Disease: A Multicenter Effectiveness-Implementation Study. J Neurol Phys Ther. 2020 Jan;44(1):15-22. doi: 10.1097/NPT.0000000000000298.
PubMed 31834166Conklin SJ, Albrecht F, Hooyman A, Peterson D, Franzen E, Longhurst JK. Identifying Predictors of Discordance Between Balance Perception and Ability in Parkinson Disease. J Neurol Phys Ther. 2026 Oct 1;50(4):232-242. doi: 10.1097/NPT.0000000000000556. Epub 2026 Apr 17.
PubMed 41992280Leavy B, Joseph C, Kwak L, Franzen E. Implementation of highly challenging balance training for Parkinson's disease in clinical practice: a process evaluation. BMC Geriatr. 2021 Feb 1;21(1):96. doi: 10.1186/s12877-021-02031-1.
PubMed 33526031Leavy B, Kwak L, Hagstromer M, Franzen E. Evaluation and implementation of highly challenging balance training in clinical practice for people with Parkinson's disease: protocol for the HiBalance effectiveness-implementation trial. BMC Neurol. 2017 Feb 7;17(1):27. doi: 10.1186/s12883-017-0809-2.
PubMed 28173775
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Highly Challenging Balance Training for People With Parkinson's Disease (the BETA-PD Study): Non-randomized Hybrid Effectiveness-implementation Trial
- ClinicalTrials.gov ID
- NCT02727478
- Acronym / sponsor ID
- BETA-PD / 2016/210-31/2
- Conditions
- Parkinson Disease
- Keywords
- Balance, Rehabilitation, Exercise, basal ganglia, Gait, Training, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 28 Mar 2016 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This effectiveness-implementation study is a part of the larger study BETA-PD (Balance, Elderly, Training and Activity in Parkinson's Disease), which has the long-term goal to reduce the risk of falling in people with Parkinson's disease (PD) by improving balance, gait and physical activity level. The main hypothesis is that highly challenging balance training will lead to greater gait and balance ability, increased levels of physical activity and an improved health related quality of life. The main aims of the study are to evaluate the effectiveness of the HiBalance program in real-life clinical settings, while exploring facilitators and barriers for program implementation on a wider scale.
Detailed description
The clinical features of PD include progressive postural instability, hypokinesia, tremor and rigidity. It is therefore common that people with PD experience reduced balance and gait function, symptoms which can have far-reaching negative effects on their health and quality of life. Injurious falls and fear of falling are especially prevalent among those with PD, a factor which may partly explain why this group are less physically active than older people of a similar age without the diagnosis. Balance and gait training, on the other hand, have been shown effective in PD and also appear to have potential neuro-protective properties. Research in the area of balance training in PD disease however is sparse and previous interventions have been criticized for applying training stimuli which lacked intensity and challenge.
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 program was developed to affect symptom-specific balance impairments in PD by targeting four main subsystems underlying balance control (stability limits, anticipatory postural adjustments, sensory integration and motor agility). The intervention consists of a 10-week progressive balance training program in group format (5-7 participants). Each training session is conducted by a minimum of 2 physiotherapist trainers, during twice weekly 1-hour sessions (20 hours in total). Additionally, a home-exercise program is carried out by the participants once a week during the trial period. The difficulty level of the group-based training is increased in three consecutive blocks. To ensure highly challenging exercises, each task is individually adjusted by altering the area of base of support, increasing movement speed/amplitude and/or restricting vision and varying the grade of multitasking. The program has previously been proven feasible [Conradsson, 2012] and effective [Conradsson, 2015] in improving balance and gait impairments in a randomized controlled hospital setting. In addition, favorable transfer effects were seen in relation to physical activity levels and the performance of activities of everyday life.
For research interventions to be adopted in real-life clinical settings however a level of adaptation is required. Best practice then involves evaluating the effectiveness of efficacious programs in clinical settings, in order to verify whether or not the adaptation has attenuated the effective core elements of the program itself.
The current study combines a clinical effectiveness trial together with implementation research. Use of a type-1 hybrid design will allow the effects of the HiBalance program in clinical settings to be tested while simultaneously gathering information on barriers and facilitators to the implementation process [Curran, 2012]. Use of the hybrid design also allows for constant monitoring of the process by which the intervention is applied, and therefore allow problems in early application to be identified and quickly altered so as to ensure better outcomes. A participatory approach will be adhered to whereby 'users' of the program (physiotherapist trainers) will be actively involved in all stages of the program adaptation, process and outcome evaluation. This approach is recommended in order to increase the relevance, acceptability and successful implementation of the program. The Consolidated Framework for Implementation Research (CFIR) will be used in the current study to guide the investigation of potential barriers to and facilitators of the implementation process [Damschroder, 2009 ].
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance training group | Experimental | Other: HiBalance training program1 hour group balance training twice weekly for 10 weeks, as well as perform a home exercise program. |
| Control group | No intervention | –Subjects in this group will receive no intervention and will be advised to continue their normal level of exercise throughout the intervention period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed idiopathic Parkinson's Disease
- Measured balance impairment (according to the mini-BESTest)
- Hoehn and Yahr stages 2-3
- Independent ambulator indoors without a walking aid
Key exclusion criteria (2 listed)
- Cognitive impairment which hinders participation in group training
- The presence of comorbidities which hinder safe participation in group training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HiBalance training programThe program consists of physiotherapist led highly challenging balance exercises, which are adapted and progressed on both a group and individual basis throughout the training period. | Other | Balance training group |
Primary outcome
Change in Mini-BESTest Score From Baseline at 1 Week Post Intervention.
Time frame: Change in Mini-BESTest score from baseline at 1 week post intervention.
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 The mini-BESTest is an assessment of balance performance and will be performed by the physiotherapists in the respective clinics.
6 secondary outcomes
Change in 10-meter Walking Test Score From Baseline at 1 Week Post Intervention.
Time frame: From baseline at 1 week post intervention.
Change in Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention.
Time frame: From baseline at 1 week post intervention.
Change in EQ-5D Score From Baseline at 1week Post Intervention.
Time frame: From baseline at 1week post intervention.
Change in Activities-specific Balance Confidence (ABC) Scale
Time frame: From baseline at 1 week post intervention.
Change in Physical Activity Level From Baseline 1 Week Post Intervention.
Time frame: from baseline to 1 week post intervention
Change in Dual Task Interference During the Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention.
Time frame: From baseline at 1 week post intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23017069Conradsson D, Lofgren N, Stahle A, Hagstromer M, Franzen E. A novel conceptual framework for balance training in Parkinson's disease-study protocol for a randomised controlled trial. BMC Neurol. 2012 Sep 27;12:111. doi: 10.1186/1471-2377-12-111.
- Background: PubMed 25608520Conradsson D, Lofgren N, Nero H, Hagstromer M, Stahle A, Lokk J, Franzen E. The Effects of Highly Challenging Balance Training in Elderly With Parkinson's Disease: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2015 Oct;29(9):827-36. doi: 10.1177/1545968314567150. Epub 2015 Jan 21.
- Background: PubMed 22310560Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
- Background: PubMed 19664226Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
- Results publication: PubMed 31834166Leavy B, Joseph C, Lofgren N, Johansson H, Hagstromer M, Franzen E. Outcome Evaluation of Highly Challenging Balance Training for People With Parkinson Disease: A Multicenter Effectiveness-Implementation Study. J Neurol Phys Ther. 2020 Jan;44(1):15-22. doi: 10.1097/NPT.0000000000000298.
- Derived from this study: PubMed 41992280Conklin SJ, Albrecht F, Hooyman A, Peterson D, Franzen E, Longhurst JK. Identifying Predictors of Discordance Between Balance Perception and Ability in Parkinson Disease. J Neurol Phys Ther. 2026 Oct 1;50(4):232-242. doi: 10.1097/NPT.0000000000000556. Epub 2026 Apr 17.
- Derived from this study: PubMed 33526031Leavy B, Joseph C, Kwak L, Franzen E. Implementation of highly challenging balance training for Parkinson's disease in clinical practice: a process evaluation. BMC Geriatr. 2021 Feb 1;21(1):96. doi: 10.1186/s12877-021-02031-1.
- Derived from this study: PubMed 28173775Leavy B, Kwak L, Hagstromer M, Franzen E. Evaluation and implementation of highly challenging balance training in clinical practice for people with Parkinson's disease: protocol for the HiBalance effectiveness-implementation trial. BMC Neurol. 2017 Feb 7;17(1):27. doi: 10.1186/s12883-017-0809-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika Franzén, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HiBalance training program in people with Parkinson Disease, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mini-BESTest Score From Baseline at 1 Week Post Intervention. (time frame: Change in Mini-BESTest score from baseline at 1 week post intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02727478, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.