Fall InjuryNCT04529200
Effects of Comprehensive Fall Prevention Protocol (CARE: Cognitive-Aerobic-Resistance-Exer-gaming) on Mobility Level in Elderly
A study testing electrotherapy treatment in people with Fall Injury and Fall Patients, run by Isra University at 1 site in Pakistan.
Trial summary
Lack of research oriented health care facilities especially rehabilitation department in Pakistan. 30-50 % of population of age 65 years and above have some problems with balance (3) and 75 % of people aging 70 years and above have poor balance which leads to fall related injuries (5). Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Fall Injury, Fall Patients, Geriatric Fall
- What is being tested?
- electrotherapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jan 2019to 30 Dec 2020
- 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
- Individuals of age 60 -80 years
- Either gender
- Berg balance score between 20-40
Who cannot join
- • Musculoskeletal conditions (fractures, severe arthritis)
- Neurological conditions like Epilepsy, Parkinson,
- Alzheimer's, Impaired cognition
- Other systemic diseases or co-morbidities
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Isra University
Islamabad, Capital, 44000
imran rafiq, PHD*, +923006460439, drimranppdpt@gmail.com
usman janjua, PHD*, +923214109550, usmanjanjua84@hotmail.com
About this study
Lack of research oriented health care facilities especially rehabilitation department in Pakistan. 30-50 % of population of age 65 years and above have some problems with balance (3) and 75 % of people aging 70 years and above have poor balance which leads to fall related injuries (5). So fall and related injuries are major problem in this age group. All studies conducted so far addresses only one or two aspects of balance training not to all. This study will address all the aspects and develop a comprehensive balance training protocol and will try to contribute to this under research area.
Read the detailed description
Lack of research oriented health care facilities especially rehabilitation department in Pakistan. 30-50 % of population of age 65 years and above have some problems with balance (3) and 75 % of people aging 70 years and above have poor balance which leads to fall related injuries (5). So fall and related injuries are major problem in this age group. All studies conducted so far addresses only one or two aspects of balance training not to all. This study will address all the aspects and develop a comprehensive balance training protocol and will try to contribute to this under research area.
Cost effective treatment for patients. To meet the expectation of patient to improve their quality of life and improvement of their satisfactory level. It will be interesting for patient to visualize the activity patient is performing and comparison of effectiveness of comprehensive fall prevention protocol with traditional balance training.
It will reduce the occurrence of fall episodes and hence reduce the cost to treat these fall and fall related injuries. Older adult will be less dependent, and more mobile and contributing member of the community.
Objectives
The objectives of the study are:
- To compare the effect of comprehensive fall prevention protocol (CARE) on fall risk as compared to conventional training in elderly.
- To compare the effect of comprehensive fall prevention protocol (CARE) on Mobility Level as compared to conventional training in elderly.
- To compare the effect of comprehensive fall prevention protocol (CARE) on Wii Fit balance as compared to conventional training in elderly.
- To compare the effect of comprehensive fall prevention protocol (CARE) on Dynamic Balance as compared to conventional training in elderly.
- To compare the effect of comprehensive fall prevention protocol (CARE) on Quality of life as compared to conventional training in elderly.
- Conditions
- Fall Injury, Fall Patients, Geriatric Fall, Physical Therapy, Balance Traiing
- Being tested
- electrotherapy treatment
- Keywords
- geriatric, fall, balance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrotherapy treatmentOther
physical therapy management like EMS IFT
| Study group | Role | What they receive |
|---|---|---|
| 1. Comprehensive fall prevention protocol group (CARE) | Experimental | every week protocol change for every patient according to 1 repetition maximum Receives: Other: electrotherapy treatment |
| 2. Conventional balance training group | Active comparator | conventional protocol commonly used for rehabilitation Receives: Other: electrotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elderly mobility scale
questionaire used to evaluate condition of elders
Measured: 8 week
Timed Up and go test (TUG)
questionaire used to evaluate mobility
Measured: 8 week
Berg Balance Test
questionaire used to evaluate balance
Measured: 8 week
Activities of Balance Confidence
questionaire used to evaluate balance
Measured: 8 week
Fullerton Advanced Balance (FAB) Scale
questionaire used to evaluate function of balance in older adult
Measured: 8 week
Functional reach test
This test measures the distance between the length of an outstretched arm in a maximal forward reach from a standing position,while maintaining a fixed base of support.
Measured: 8 week
Dynamic gait index
The Dynamic Gait Index (DGI) was developed as a clinical tool to assess gait, balance and fall risk.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start5 Jan 2019
- Primary completion10 Nov 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall InjuryStudies 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
- Model description
- Total 40 patients fulfilling the inclusion criteria will be included in this study. Treatment will be given 3 times a week for 24 weeks by researcher with each session lasting for 40 to 45 Minutes. Assessment will then be done at baseline, after 04, 08, 12 and 24 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isra University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, imran rafiq, Isra University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529200
- Sponsor's protocol ID
- 1502-PHD-004
- Status last verified
- Aug 2020
- First submitted
- 24 Aug 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Comprehensive Fall Prevention Protocol (CARE: Cognitive-Aerobic-Resistance-Exer-gaming) on Mobility Level in Elderly
- ClinicalTrials.gov ID
- NCT04529200
- Acronym / sponsor ID
- 1502-PHD-004
- Conditions
- Fall Injury, Fall Patients, Geriatric Fall, Physical Therapy, Balance Traiing
- Keywords
- geriatric, fall, balance training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Isra UniversityUniversity, hospital or other
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 10 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 27 Aug 2020 (actual)
- 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.
Lack of research oriented health care facilities especially rehabilitation department in Pakistan. 30-50 % of population of age 65 years and above have some problems with balance (3) and 75 % of people aging 70 years and above have poor balance which leads to fall related injuries (5). So fall and related injuries are major problem in this age group. All studies conducted so far addresses only one or two aspects of balance training not to all. This study will address all the aspects and develop a comprehensive balance training protocol and will try to contribute to this under research area.
Detailed description
Lack of research oriented health care facilities especially rehabilitation department in Pakistan. 30-50 % of population of age 65 years and above have some problems with balance (3) and 75 % of people aging 70 years and above have poor balance which leads to fall related injuries (5). So fall and related injuries are major problem in this age group. All studies conducted so far addresses only one or two aspects of balance training not to all. This study will address all the aspects and develop a comprehensive balance training protocol and will try to contribute to this under research area.
Cost effective treatment for patients. To meet the expectation of patient to improve their quality of life and improvement of their satisfactory level. It will be interesting for patient to visualize the activity patient is performing and comparison of effectiveness of comprehensive fall prevention protocol with traditional balance training.
It will reduce the occurrence of fall episodes and hence reduce the cost to treat these fall and fall related injuries. Older adult will be less dependent, and more mobile and contributing member of the community.
Objectives
The objectives of the study are:
- To compare the effect of comprehensive fall prevention protocol (CARE) on fall risk as compared to conventional training in elderly.
- To compare the effect of comprehensive fall prevention protocol (CARE) on Mobility Level as compared to conventional training in elderly.
- To compare the effect of comprehensive fall prevention protocol (CARE) on Wii Fit balance as compared to conventional training in elderly.
- To compare the effect of comprehensive fall prevention protocol (CARE) on Dynamic Balance as compared to conventional training in elderly.
- To compare the effect of comprehensive fall prevention protocol (CARE) on Quality of life as compared to conventional training in elderly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Total 40 patients fulfilling the inclusion criteria will be included in this study. Treatment will be given 3 times a week for 24 weeks by researcher with each session lasting for 40 to 45 Minutes. Assessment will then be done at baseline, after 04, 08, 12 and 24 weeks.
| Arm | Type | Receives |
|---|---|---|
| 1. Comprehensive fall prevention protocol group (CARE) | Experimental | Other: electrotherapy treatmentevery week protocol change for every patient according to 1 repetition maximum |
| 2. Conventional balance training group | Active comparator | Other: electrotherapy treatmentconventional protocol commonly used for rehabilitation |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals of age 60 -80 years
- Either gender
- Berg balance score between 20-40
Key exclusion criteria (4 listed)
- • Musculoskeletal conditions (fractures, severe arthritis)
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 |
|---|---|---|
| electrotherapy treatmentphysical therapy management like EMS IFT | Other | 1. Comprehensive fall prevention protocol group (CARE), 2. Conventional balance training group |
Primary outcome
Elderly mobility scale
Time frame: 8 week
questionaire used to evaluate condition of elders
Timed Up and go test (TUG)
Time frame: 8 week
questionaire used to evaluate mobility
Berg Balance Test
Time frame: 8 week
questionaire used to evaluate balance
Activities of Balance Confidence
Time frame: 8 week
questionaire used to evaluate balance
Fullerton Advanced Balance (FAB) Scale
Time frame: 8 week
questionaire used to evaluate function of balance in older adult
Functional reach test
Time frame: 8 week
This test measures the distance between the length of an outstretched arm in a maximal forward reach from a standing position,while maintaining a fixed base of support.
Dynamic gait index
Time frame: 8 week
The Dynamic Gait Index (DGI) was developed as a clinical tool to assess gait, balance and fall risk.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrotherapy treatment in people with Fall Injury and Fall Patients, run by Isra University at 1 site in Pakistan.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Aug 2020. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Rafique, Ph.D (+923006460439, drimranppdpt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elderly mobility scale (time frame: 8 week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2020.