NCT02727478

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

March 28, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2018

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

August 14, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

1.9 years

First QC Date

March 22, 2016

Results QC Date

January 11, 2022

Last Update Submit

August 11, 2023

Conditions

Parkinson Disease

Keywords

BalanceRehabilitationExercisebasal gangliaGaitTrainingphysical activity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in 10-meter Walking Test Score From Baseline at 1 Week Post Intervention.

    From baseline at 1 week post intervention.

  • Change in Timed Up and Go (TUG) Test From Baseline at 1 Week Post Intervention.

    From baseline at 1 week post intervention.

  • Change in EQ-5D Score From Baseline at 1week Post Intervention.

    From baseline at 1week post intervention.

  • Change in Activities-specific Balance Confidence (ABC) Scale

    From baseline at 1 week post intervention.

  • Change in Physical Activity Level From Baseline 1 Week Post Intervention.

    from baseline to 1 week post intervention

  • +1 more secondary outcomes

Study Arms (2)

Balance training group

EXPERIMENTAL

1 hour group balance training twice weekly for 10 weeks, as well as perform a home exercise program.

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.

Interventions

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.

Balance training group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska institutet

Stockholm, Södermanland County, 14183, Sweden

Location

Related Publications (7)

  • 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.

    PMID: 23017069BACKGROUND

  • 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.

    PMID: 25608520BACKGROUND

  • 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.

    PMID: 22310560BACKGROUND

  • 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.

    PMID: 19664226BACKGROUND

  • 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. doi: 10.1097/NPT.0000000000000298.

    PMID: 31834166RESULT

  • Leavy 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.

    PMID: 33526031DERIVED

  • Leavy 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.

    PMID: 28173775DERIVED

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Results Point of Contact

Title
Dr Breiffni Leavy
Organization
Karolinska Instituet
breiffni.leavy@ki.se
+46852488814

Study Officials

  • Erika Franzén, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 22, 2016

First Posted

April 4, 2016

Study Start

March 28, 2016

Primary Completion

February 20, 2018

Study Completion

September 28, 2018

Last Updated

August 14, 2023

Results First Posted

August 14, 2023

Record last verified: 2023-08

Locations

SE(1)