Effectiveness and Implementation of the HiBalance Program in Clinical Practice

Parkinson Disease Clinical Trial

— BETA-PD  

Official title:

Highly Challenging Balance Training for People With Parkinson's Disease (the BETA-PD Study): Non-randomized Hybrid Effectiveness-implementation Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727478
• Other study ID #: 2016/210-31/2
• Status: Completed
• Phase: N/A
• Start date: March 28, 2016
• Est. completion date: September 28, 2018

Study information

• Verified date: August 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 ].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: September 28, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Cognitive impairment which hinders participation in group training

• The presence of comorbidities which hinder safe participation in group training

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• HiBalance training program
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.

Locations

Country	Name	City	State
Sweden	Karolinska institutet	Stockholm	Södermanland

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

Conradsson 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. — View Citation

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. — View Citation

Curran 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. — View Citation

Damschroder 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. — View Citation

Leavy 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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change in Mini-BESTest score from baseline at 1 week post intervention.
Secondary	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	From baseline at 1 week post intervention.
Secondary	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.	From baseline at 1 week post intervention.
Secondary	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	From baseline at 1week post intervention.
Secondary	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%.	From baseline at 1 week post intervention.
Secondary	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)	from baseline to 1 week post intervention
Secondary	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.	From baseline at 1 week post intervention.