Distorted; BalanceNCT02333994
Efficacy of Education With Balance Exercise in Improving Balance and Reducing the Fear of Falls in Elderly
A study testing GROUP A education programme as well as balance training exercises and GROUP B on-platform training in people with Distorted; Balance, run by Maharishi Markendeswar University (Deemed to be University).
Trial summary
The aim of the study was to evaluate the Efficacy of Education With Balance Exercise in Reducing Fear of Falls in Elderly Population . In the present study the educational program along with balance training was delivered to group A, (Experimental group) and only Balance training was delivered to group B, (Control… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Distorted; Balance
- What is being tested?
- GROUP A education programme as well as balance training exercises and GROUP B on-platform training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly
- Both males and females were included in the study.
- Individuals with Mini Mental Status Examination score >23.
- History of falls in last 6 months
Who cannot join
- Any musculoskeletal disorder
- Any visual deficit
- Any systemic disease
- Any Neurological Disorder
- Any Cardiovascular and Respiratory Disorder
- Now cooperative Individuals
- Any Psychological disorder
About this study
The aim of the study was to evaluate the Efficacy of Education With Balance Exercise in Reducing Fear of Falls in Elderly Population . In the present study the educational program along with balance training was delivered to group A, (Experimental group) and only Balance training was delivered to group B, (Control group) for 6 weeks for 1 hr duration once weekly. Education program included education about the risk factors of falls such as environmental hazards, importance of good nutrition, use of stick while walking, avoiding slippery surfaces. Balance training consists of stance activities and balance exercise program. The outcome measures for this intervention were Activities specific balance confidence scale and berg balance scale.
Read the detailed description
Present study was an experimental design. A total of 60 elderly subjects were selected as per the selection criteria and they were randomly allocated in two equal groups i.e.Group A- (Experimental Group)- Balance Exercises and Education Program Group B - (Control Group) - Balance exercises.procedure of study was explained to each subject and written consent was taken from them.
Aim:
The aim of the study was to evaluate the Efficacy of Education With Balance Exercise in Reducing Fear of Falls in Elderly Population .
Materials and Methods In the present study the educational program along with balance training was delivered to group A, (Experimental group) and only Balance training was delivered to group B, (Control group) for 6 weeks for 1 hr duration once weekly. Education program included education about the risk factors of falls such as environmental hazards, importance of good nutrition, use of stick while walking, avoiding slippery surfaces. Balance training consists of stance activities and balance exercise program. The outcome measures for this intervention were Activities specific balance confidence scale and berg balance scale.
- Conditions
- Distorted; Balance
- Being tested
- GROUP A education programme as well as balance training exercises, GROUP B on-platform training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GROUP A education programme as well as balance training exercisesDevice
Group A received education programme as well as balance training exercises.The intervention group attended one-hour training classes once a week for 6 consecutive weeks. The classes involved both lectures and discussions and were guided through with handouts and worksheets. Each session began by giving a summary of the previous session and continued with the main topic of the session. The intervention program also engaged the participants in discussions about their concerns regarding falling and on topics pertaining to identifying and reducing the risk factors of falls, including environmental hazards in and out of the house
GROUP B on-platform trainingOther
Also called BALANCE TRAINING
on-platform training was performed while standing and while sitting on a 22-inch therapeutic ball, 1 eyes open or closed 2 normal or reduced area of foot support 3 on foam or floor 4 with or without manual p
| Study group | Role | What they receive |
|---|---|---|
| GROUP A | Experimental | EDUCATION PROGRAMME AND BALANCE TRAINING EXERCISES Receives: Device: GROUP A education programme as well as balance training exercises |
| GROUP B | Active comparator | BALANCE EXERCISES Receives: Other: GROUP B on-platform training |
What is being measured
The primary outcome is the main question the study is designed to answer.
BERG BALANCE SCALE
Measured: 6 weeks
Secondary outcomes (1)
ACTIVITY BALANCE CONFIDENCE SCALE
Measured: 6 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distorted; BalanceStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DIVYA MIDHA, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- DIVYA MIDHA, MPT(NEURO), Principal investigator, MAHARISHI MARKANDESHWAR UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333994
- Sponsor's protocol ID
- D3456
- Status last verified
- Jan 2015
- First submitted
- 1 Jan 2015
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.
PubMed 39360568
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Education With Balance Exercise in Improving Balance and Reducing the Fear of Falls in Elderly
- ClinicalTrials.gov ID
- NCT02333994
- Acronym / sponsor ID
- D3456
- Conditions
- Distorted; Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study was to evaluate the Efficacy of Education With Balance Exercise in Reducing Fear of Falls in Elderly Population . In the present study the educational program along with balance training was delivered to group A, (Experimental group) and only Balance training was delivered to group B, (Control group) for 6 weeks for 1 hr duration once weekly. Education program included education about the risk factors of falls such as environmental hazards, importance of good nutrition, use of stick while walking, avoiding slippery surfaces. Balance training consists of stance activities and balance exercise program. The outcome measures for this intervention were Activities specific balance confidence scale and berg balance scale.
Detailed description
Present study was an experimental design. A total of 60 elderly subjects were selected as per the selection criteria and they were randomly allocated in two equal groups i.e.Group A- (Experimental Group)- Balance Exercises and Education Program Group B - (Control Group) - Balance exercises.procedure of study was explained to each subject and written consent was taken from them.
Aim:
The aim of the study was to evaluate the Efficacy of Education With Balance Exercise in Reducing Fear of Falls in Elderly Population .
Materials and Methods In the present study the educational program along with balance training was delivered to group A, (Experimental group) and only Balance training was delivered to group B, (Control group) for 6 weeks for 1 hr duration once weekly. Education program included education about the risk factors of falls such as environmental hazards, importance of good nutrition, use of stick while walking, avoiding slippery surfaces. Balance training consists of stance activities and balance exercise program. The outcome measures for this intervention were Activities specific balance confidence scale and berg balance scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A | Experimental | Device: GROUP A education programme as well as balance training exercisesEDUCATION PROGRAMME AND BALANCE TRAINING EXERCISES |
| GROUP B | Active comparator | Other: GROUP B on-platform trainingBALANCE EXERCISES |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elderly
- Both males and females were included in the study.
- Individuals with Mini Mental Status Examination score >23.
- History of falls in last 6 months
Key exclusion criteria (7 listed)
- Any musculoskeletal disorder
- Any visual deficit
- Any systemic disease
- Any Neurological Disorder
- Any Cardiovascular and Respiratory Disorder
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 |
|---|---|---|
| GROUP A education programme as well as balance training exercisesGroup A received education programme as well as balance training exercises.The intervention group attended one-hour training classes once a week for 6 consecutive weeks. The classes involved both lectures and discussions and were guided through with handouts and worksheets. Each session began by giving a summary of the previous session and continued with the main topic of the session. The intervention program also engaged the participants in discussions about their concerns regarding falling and on topics pertaining to identifying and reducing the risk factors of falls, including environmental hazards in and out of the house | Device | GROUP A |
| GROUP B on-platform trainingAlso: BALANCE TRAININGon-platform training was performed while standing and while sitting on a 22-inch therapeutic ball, 1 eyes open or closed 2 normal or reduced area of foot support 3 on foam or floor 4 with or without manual p | Other | GROUP B |
Primary outcome
BERG BALANCE SCALE
Time frame: 6 weeks
1 secondary outcome
ACTIVITY BALANCE CONFIDENCE SCALE
Time frame: 6 WEEKS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
- Derived from this study: PubMed 39360568Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.
Related trials for Distorted; Balance
Recruiting
Balance Rehabilitation With Modified Visual Input in Patients With Neuropathy
Neuropathy, Ataxia
Recruiting
Innovative Approaches to Enhance Balance and Neuroplasticity in Multiple Sclerosis
Multiple Sclerosis, Mobility Limitation
Recruiting
Effect of Functional Core Stability Training or Cognitive Training on Balance and Postural Control in Chronic Ankle Instability
Cognitive Training, Functional Core Stability Training
Recruiting
Effects of Otago and Gaze Stabilization Exercises on Balance, Gait and QOL in Elderly Stroke Patients
Balance; Distorted, Gait, Hemiplegic
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.
DIVYA MIDHA, MPT(NEURO) principal investigator
MAHARISHI MARKANDESHWAR UNIVERSITY
Questions about this trial
What is this clinical trial studying?
A study testing GROUP A education programme as well as balance training exercises and GROUP B on-platform training in people with Distorted; Balance, run by Maharishi Markendeswar University (Deemed to be University).
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 7 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 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BERG BALANCE SCALE (time frame: 6 weeks). 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 NCT02333994, which also lists 1 linked publication.
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 8 Jan 2015.