Hip FractureNCT04626934
Cognitive Intervention and Rehabilitation Outcomes in Hip Fracture Patients
A study testing specific cognitive intervention and conventional occupational therapy treatment in people with Hip Fracture and Rehabilitation, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The objective of the present study is to assess whether specific cognitive intervention will influence rehabilitation outcomes of post-acute hip fracture patients. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Hip Fracture, Rehabilitation, Cognitive Intervention
- What is being tested?
- specific cognitive intervention and conventional occupational therapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2020to 1 Oct 2024
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- All concecutive hip fracture patients admitted to a post-acute rehabilitation ward Mini mental state examination above 17 Lived at home before the fracture and did not recieved 24 hour home aid
Who cannot join
- Patients who will not complete rehabilitation program due to worsening of their medical condition or unexpectedly cease rehabilitation will be omitted from the statistical analyses.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
"Beit- Rivka" geriatric rehabilitation hospital
Petach Tiqva
Avital Hershkovitz, MD-PhD, +972522342123, avitalhe@clalit.org.il
yedida Borow, BOT, +972546441838, yedidabo@clalit.org.il
About this study
Official title: Can Specific Cognitive Intervention With Post-Acute Cognitively Impaired Hip Fracture Patients Improve Rehabilitation Outcome
The objective of the present study is to assess whether specific cognitive intervention will influence rehabilitation outcomes of post-acute hip fracture patients.
Read the detailed description
Hip fracture often occurs in frail older people and is a major concern for the health care systems because it is associated with an up to 36% excess mortality within 1 year. Hip fracture also represents a risk factor for further falls and fractures, functional decline and institutionalization, with <40% of hip fractured patients regaining their pre-injury level of ambulation.
One of the most challenging tasks of today's post-acute geriatric rehabilitation wards is improving the functional abilities of fragile hip-fractured patients and discharging most of them to their homes. Yet, the rising incidence of hip fractures in the elderly has created an overwhelming workload on those departments and has significantly increased the burden on healthcare resources. Previous studies have found that cognitive decline is an important negative predictor in rehabilitation. Several studies have shown that cognitive interventions can improve functional abilities of older people. Yet, these studies were conducted in community dwelling older people. Our study will assess this issue amongst post-acute rehabilitation hip fracture patients. Our hypotyhesis is that those patients recieving specific cognitive intervention will show significantly better rehabilitation outcomes and cognitive function.
The objective of the present study is to assess whether specific cognitive intervention will influence rehabilitation outcomes of post-acute hip fracture patients.
This is a randomized double blinded study. We will compare two groups: one will recieve specific cognitive intervention and a control group will recieve conventional occupational therapy treatment. Both groups will recieve the same amount of interventions.The interventions will include all together 12 sessions, each being 45 minutes, for a total of 3 weeks. The intervention will include: 4 treatments in the area of memory and attention, 4 treatments in the area of problem solving, 4 treatments in the area of planning and analysing.
Patients in the control group will recieve conventional occupational therapy treatment: 3 weeks of all together 12 sessions, 45 minutes each.
The outcome measures are: a disability measure, the Functional Independence Measure (FIM), the motor FIM, the Montebello Rehabilitation Factor Score (MRFS), also called motor FIM effectiveness. In addition 4 cognitive functional measures: the Color Trail Test, the Kettle Test, the Groningen Activity Restriction Skill (GARS), the Montreal Cognitive Assessment (MOCA).
The randomization process will be carried out by withdrawing a piece of paper written either A (intervention) (n=10) or B (control) (n=10) from an envelope. The subjects will not be informed as to which group they will be assigned. Patient recruitment and the randomization process will be supervised by the clinical staff. The assessors will be blinded to the type of intervention.
Statistical analysis will be performed using the IBM SPSS Statistics for Windows (Version 25.0. Armonk, NY: IBM Corp.).
The study sample size was estimated using the mean and the standard deviation of the motor FIM measure (calculated for this population), with improvement assumption by 7 points, with power of 0.8 and significance level of 0.05.
- Conditions
- Hip Fracture, Rehabilitation, Cognitive Intervention
- Being tested
- specific cognitive intervention, conventional occupational therapy treatment
- Keywords
- cognitive, Intervention, Hip fracture, Rehabilitation, outcomes
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specific cognitive interventionOther
The intervention will include all together 12 sessions, each being 45 minutes, for a total of 3 weeks. The intervention will include: 4 treatments in the area of memory and attention, 4 treatments in the area of problem solving, 4 treatments in the area of planning and analysing.
conventional occupational therapy treatmentOther
The intervention will include all together 12 sessions of conventional occupational therapy treatments, each being 45 minutes, for a total of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Patients in the control group will recieve conventional occupational therapy treatment: 3 weeks of all together 12 sessions, 45 minutes each. Receives: Other: conventional occupational therapy treatment |
| Intervention group | Experimental | The intervention will include all together 12 sessions, each being 45 minutes, for a total of 3 weeks. The intervention will include: 4 treatments in the area of memory and attention, 4 treatments in the area of problem solving, 4 treatments in the area of planning and analysing. Receives: Other: specific cognitive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure (FIM)
The FIM is a disability measure, administered on admission and upon discharge to assess change in functional abilities. The FIM comprises 18 parameters, each rated on a scale of 1 to 7 according to the degree of assistance required to perform a specific activity in 3 domains: activities of daily living (ADL) (8 parameters), mobility level (5 parameters) and cognitive function (5 parameters). The maximal total score for the FIM is 126. The patient's FIM score will be assessed during multi-disciplinary team meeting
Measured: The change in the measure from randomization until the date of discharge, assessed up 3 months.
motor Functional Independence Measure (mFIM)
The motor FIM (mFIM) includes 13 parameters of ADL and mobility. maximal total score for the mFIM is 91. The patient's motor FIM score was assessed during multi-disciplinary team meeting
Measured: The change in the measure from randomization until the date of discharge, assessed up 3 months.
The Montebello Rehabilitation Factor Score (MRFS)
The MRFS achieved on the mFIM score is calculated by the Montebello Rehabilitation Factor Score (MRFS), designed to overcome the floor and ceiling effect problem and calculate each patient's specific potential for improvement. The MRFS also known as mFIM effectiveness, will be calculated as the mFIM score change (discharge mFIM score-admission mFIM score) divided by the mFIM maximum score (91) minus the mFIM admission score.
Measured: The score will be calculated at discharge, assessed up to 3 months from randomization.
Secondary outcomes (5)
Color Trail Test
Assesses attention and visual perception and flexible thinking
Measured: The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
Kettle Test
Assesses working memory, attention, problem solving, praxis and safety
Measured: The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
Groningen Activity Restriction Scale
Assesses level of disability. This tool is comrised of 18 parameters each rated on a scale of 1 to 5. A low score shows higher functional level
Measured: The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
Montreal Cognitive Assessement (MOCA)
Assesses basic and executive cognitive skills. This tool includes 5 points related to executive function, 3 points to naming, 6 points to attention, 3 points to language use, 2 points to abstract thinking, 5 points to short term memory and 6 points to orientation. A score of 26 points and above shows normal cognitive functioning.
Measured: The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
EQ-5D (EuroQol Group)
EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. It ia applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys. EQ-5D is designed for self-completion by respondents and is ideally suited for use in postal surveys, in clinics, and in face-to-face interviews. It is cognitively undemanding, taking only a few minutes to complete.
Measured: The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies 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
- Randomized double blinded study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Principal investigator, AVITAL HERSHKOVITZ, Rabin Medical Center
- Investigators
- Avital Hershkovitz, MD, Principal investigator, Rabin MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626934
- Sponsor's protocol ID
- 0465-20-RMC
- Status last verified
- Apr 2023
- First submitted
- 22 Oct 2020
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adam S, Godlwana L, Maleka D. Changes in short-term cognitive function following a hip fracture in the elderly and the effect of cognitive function on early post-operative function. SA Orthopaedic Journal 2016;15:77-82.
Oughli HA, Chen G, Philip Miller J, Nicol G, Butters MA, Avidan M, Stark S, Lenze EJ. Cognitive Improvement in Older Adults in the Year After Hip Fracture: Implications for Brain Resilience in Advanced Aging. Am J Geriatr Psychiatry. 2018 Nov;26(11):1119-1127. doi: 10.1016/j.jagp.2018.07.001.
PubMed 30454790Beloosesky Y, Grinblat J, Epelboym B, Weiss A, Grosman B, Hendel D. Functional gain of hip fracture patients in different cognitive and functional groups. Clin Rehabil. 2002 May;16(3):321-8. doi: 10.1191/0269215502cr497oa.
PubMed 12017519Rolland Y, Pillard F, Lauwers-Cances V, Busquere F, Vellas B, Lafont C. Rehabilitation outcome of elderly patients with hip fracture and cognitive impairment. Disabil Rehabil. 2004 Apr 8;26(7):425-31. doi: 10.1080/09638280410001663148.
PubMed 15204479Gruber-Baldini AL, Hosseini M, Orwig D, Grattan L, Chiles Shaffer N, Hochberg M, Magaziner J. Cognitive Differences between Men and Women who Fracture their Hip and Impact on Six-Month Survival. J Am Geriatr Soc. 2017 Mar;65(3):e64-e69. doi: 10.1111/jgs.14674. Epub 2017 Feb 8.
PubMed 28176306Mizrahi EH, Harel N, Heymann AD, Lubart E, Leibovitz A, Malik Gadot E, Barkan RB. The relation between gain in cognition during rehabilitation on functional outcome among hip fracture adult patients with and without pre- hip fracture dementia. Arch Gerontol Geriatr. 2018 Sep-Oct;78:177-180. doi: 10.1016/j.archger.2018.06.016. Epub 2018 Jun 30.
PubMed 30006209Ball K, Berch DB, Helmers KF, Jobe JB, Leveck MD, Marsiske M, Morris JN, Rebok GW, Smith DM, Tennstedt SL, Unverzagt FW, Willis SL; Advanced Cognitive Training for Independent and Vital Elderly Study Group. Effects of cognitive training interventions with older adults: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2271-81. doi: 10.1001/jama.288.18.2271.
PubMed 12425704Lipardo DS, Tsang WW. Effects of combined physical and cognitive training on fall prevention and risk reduction in older persons with mild cognitive impairment: a randomized controlled study. Clin Rehabil. 2020 Jun;34(6):773-782. doi: 10.1177/0269215520918352. Epub 2020 May 7.
PubMed 32380917Lipardo DS, Tsang WWN. Falls prevention through physical and cognitive training (falls PACT) in older adults with mild cognitive impairment: a randomized controlled trial protocol. BMC Geriatr. 2018 Aug 24;18(1):193. doi: 10.1186/s12877-018-0868-2.
PubMed 30143002Reijnders J, van Heugten C, van Boxtel M. Cognitive interventions in healthy older adults and people with mild cognitive impairment: a systematic review. Ageing Res Rev. 2013 Jan;12(1):263-75. doi: 10.1016/j.arr.2012.07.003. Epub 2012 Jul 25.
PubMed 22841936Willis SL, Tennstedt SL, Marsiske M, Ball K, Elias J, Koepke KM, Morris JN, Rebok GW, Unverzagt FW, Stoddard AM, Wright E; ACTIVE Study Group. Long-term effects of cognitive training on everyday functional outcomes in older adults. JAMA. 2006 Dec 20;296(23):2805-14. doi: 10.1001/jama.296.23.2805.
PubMed 17179457Heruti RJ, Lusky A, Barell V, Ohry A, Adunsky A. Cognitive status at admission: does it affect the rehabilitation outcome of elderly patients with hip fracture? Arch Phys Med Rehabil. 1999 Apr;80(4):432-6. doi: 10.1016/s0003-9993(99)90281-2.
PubMed 10206606Hamilton BB, Granger CV, Sherwin FS, et al. A uniform national data system for medical rehabilitation. In: Fuhrer MJ, editor. Rehabilitation outcomes: analysis and measurement. Baltimore: Paul H Brooks Publishing Co; 1987. p 137-47.
Granger CV, Hamilton BB. The Uniform Data System for Medical Rehabilitation report of first admissions for 1992. Am J Phys Med Rehabil. 1994 Feb;73(1):51-5. No abstract available.
PubMed 8305182Hartman-Maeir A, Erez AB, Ratzon N, Mattatia T, Weiss P. The validity of the Color Trail Test in the pre-driver assessment of individuals with acquired brain injury. Brain Inj. 2008 Dec;22(13-14):994-8. doi: 10.1080/02699050802491305.
PubMed 19117177
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Specific Cognitive Intervention With Post-Acute Cognitively Impaired Hip Fracture Patients Improve Rehabilitation Outcome
- ClinicalTrials.gov ID
- NCT04626934
- Acronym / sponsor ID
- 0465-20-RMC
- Conditions
- Hip Fracture, Rehabilitation, Cognitive Intervention
- Keywords
- cognitive, Intervention, Hip fracture, Rehabilitation, outcomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 13 Nov 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.
The objective of the present study is to assess whether specific cognitive intervention will influence rehabilitation outcomes of post-acute hip fracture patients.
Detailed description
Hip fracture often occurs in frail older people and is a major concern for the health care systems because it is associated with an up to 36% excess mortality within 1 year. Hip fracture also represents a risk factor for further falls and fractures, functional decline and institutionalization, with <40% of hip fractured patients regaining their pre-injury level of ambulation.
One of the most challenging tasks of today's post-acute geriatric rehabilitation wards is improving the functional abilities of fragile hip-fractured patients and discharging most of them to their homes. Yet, the rising incidence of hip fractures in the elderly has created an overwhelming workload on those departments and has significantly increased the burden on healthcare resources. Previous studies have found that cognitive decline is an important negative predictor in rehabilitation. Several studies have shown that cognitive interventions can improve functional abilities of older people. Yet, these studies were conducted in community dwelling older people. Our study will assess this issue amongst post-acute rehabilitation hip fracture patients. Our hypotyhesis is that those patients recieving specific cognitive intervention will show significantly better rehabilitation outcomes and cognitive function.
The objective of the present study is to assess whether specific cognitive intervention will influence rehabilitation outcomes of post-acute hip fracture patients.
This is a randomized double blinded study. We will compare two groups: one will recieve specific cognitive intervention and a control group will recieve conventional occupational therapy treatment. Both groups will recieve the same amount of interventions.The interventions will include all together 12 sessions, each being 45 minutes, for a total of 3 weeks. The intervention will include: 4 treatments in the area of memory and attention, 4 treatments in the area of problem solving, 4 treatments in the area of planning and analysing.
Patients in the control group will recieve conventional occupational therapy treatment: 3 weeks of all together 12 sessions, 45 minutes each.
The outcome measures are: a disability measure, the Functional Independence Measure (FIM), the motor FIM, the Montebello Rehabilitation Factor Score (MRFS), also called motor FIM effectiveness. In addition 4 cognitive functional measures: the Color Trail Test, the Kettle Test, the Groningen Activity Restriction Skill (GARS), the Montreal Cognitive Assessment (MOCA).
The randomization process will be carried out by withdrawing a piece of paper written either A (intervention) (n=10) or B (control) (n=10) from an envelope. The subjects will not be informed as to which group they will be assigned. Patient recruitment and the randomization process will be supervised by the clinical staff. The assessors will be blinded to the type of intervention.
Statistical analysis will be performed using the IBM SPSS Statistics for Windows (Version 25.0. Armonk, NY: IBM Corp.).
The study sample size was estimated using the mean and the standard deviation of the motor FIM measure (calculated for this population), with improvement assumption by 7 points, with power of 0.8 and significance level of 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double blinded study
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: conventional occupational therapy treatmentPatients in the control group will recieve conventional occupational therapy treatment: 3 weeks of all together 12 sessions, 45 minutes each. |
| Intervention group | Experimental | Other: specific cognitive interventionThe intervention will include all together 12 sessions, each being 45 minutes, for a total of 3 weeks. The intervention will include: 4 treatments in the area of memory and attention, 4 treatments in the area of problem solving, 4 treatments in the area of planning and analysing. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- All concecutive hip fracture patients admitted to a post-acute rehabilitation ward Mini mental state examination above 17 Lived at home before the fracture and did not recieved 24 hour home aid
Key exclusion criteria (1 listed)
- Patients who will not complete rehabilitation program due to worsening of their medical condition or unexpectedly cease rehabilitation will be omitted from the statistical analyses.
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 |
|---|---|---|
| specific cognitive interventionThe intervention will include all together 12 sessions, each being 45 minutes, for a total of 3 weeks. The intervention will include: 4 treatments in the area of memory and attention, 4 treatments in the area of problem solving, 4 treatments in the area of planning and analysing. | Other | Intervention group |
| conventional occupational therapy treatmentThe intervention will include all together 12 sessions of conventional occupational therapy treatments, each being 45 minutes, for a total of 3 weeks. | Other | control group |
Primary outcome
Functional Independence Measure (FIM)
Time frame: The change in the measure from randomization until the date of discharge, assessed up 3 months.
The FIM is a disability measure, administered on admission and upon discharge to assess change in functional abilities. The FIM comprises 18 parameters, each rated on a scale of 1 to 7 according to the degree of assistance required to perform a specific activity in 3 domains: activities of daily living (ADL) (8 parameters), mobility level (5 parameters) and cognitive function (5 parameters). The maximal total score for the FIM is 126. The patient's FIM score will be assessed during multi-disciplinary team meeting
motor Functional Independence Measure (mFIM)
Time frame: The change in the measure from randomization until the date of discharge, assessed up 3 months.
The motor FIM (mFIM) includes 13 parameters of ADL and mobility. maximal total score for the mFIM is 91. The patient's motor FIM score was assessed during multi-disciplinary team meeting
The Montebello Rehabilitation Factor Score (MRFS)
Time frame: The score will be calculated at discharge, assessed up to 3 months from randomization.
The MRFS achieved on the mFIM score is calculated by the Montebello Rehabilitation Factor Score (MRFS), designed to overcome the floor and ceiling effect problem and calculate each patient's specific potential for improvement. The MRFS also known as mFIM effectiveness, will be calculated as the mFIM score change (discharge mFIM score-admission mFIM score) divided by the mFIM maximum score (91) minus the mFIM admission score.
5 secondary outcomes
Color Trail Test
Time frame: The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
Kettle Test
Time frame: The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
Groningen Activity Restriction Scale
Time frame: The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
Montreal Cognitive Assessement (MOCA)
Time frame: The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
EQ-5D (EuroQol Group)
Time frame: The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- BackgroundAdam S, Godlwana L, Maleka D. Changes in short-term cognitive function following a hip fracture in the elderly and the effect of cognitive function on early post-operative function. SA Orthopaedic Journal 2016;15:77-82.
- Background: PubMed 30454790Oughli HA, Chen G, Philip Miller J, Nicol G, Butters MA, Avidan M, Stark S, Lenze EJ. Cognitive Improvement in Older Adults in the Year After Hip Fracture: Implications for Brain Resilience in Advanced Aging. Am J Geriatr Psychiatry. 2018 Nov;26(11):1119-1127. doi: 10.1016/j.jagp.2018.07.001.
- Background: PubMed 12017519Beloosesky Y, Grinblat J, Epelboym B, Weiss A, Grosman B, Hendel D. Functional gain of hip fracture patients in different cognitive and functional groups. Clin Rehabil. 2002 May;16(3):321-8. doi: 10.1191/0269215502cr497oa.
- Background: PubMed 15204479Rolland Y, Pillard F, Lauwers-Cances V, Busquere F, Vellas B, Lafont C. Rehabilitation outcome of elderly patients with hip fracture and cognitive impairment. Disabil Rehabil. 2004 Apr 8;26(7):425-31. doi: 10.1080/09638280410001663148.
- Background: PubMed 28176306Gruber-Baldini AL, Hosseini M, Orwig D, Grattan L, Chiles Shaffer N, Hochberg M, Magaziner J. Cognitive Differences between Men and Women who Fracture their Hip and Impact on Six-Month Survival. J Am Geriatr Soc. 2017 Mar;65(3):e64-e69. doi: 10.1111/jgs.14674. Epub 2017 Feb 8.
- Background: PubMed 30006209Mizrahi EH, Harel N, Heymann AD, Lubart E, Leibovitz A, Malik Gadot E, Barkan RB. The relation between gain in cognition during rehabilitation on functional outcome among hip fracture adult patients with and without pre- hip fracture dementia. Arch Gerontol Geriatr. 2018 Sep-Oct;78:177-180. doi: 10.1016/j.archger.2018.06.016. Epub 2018 Jun 30.
- Background: PubMed 12425704Ball K, Berch DB, Helmers KF, Jobe JB, Leveck MD, Marsiske M, Morris JN, Rebok GW, Smith DM, Tennstedt SL, Unverzagt FW, Willis SL; Advanced Cognitive Training for Independent and Vital Elderly Study Group. Effects of cognitive training interventions with older adults: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2271-81. doi: 10.1001/jama.288.18.2271.
- Background: PubMed 32380917Lipardo DS, Tsang WW. Effects of combined physical and cognitive training on fall prevention and risk reduction in older persons with mild cognitive impairment: a randomized controlled study. Clin Rehabil. 2020 Jun;34(6):773-782. doi: 10.1177/0269215520918352. Epub 2020 May 7.
- Background: PubMed 30143002Lipardo DS, Tsang WWN. Falls prevention through physical and cognitive training (falls PACT) in older adults with mild cognitive impairment: a randomized controlled trial protocol. BMC Geriatr. 2018 Aug 24;18(1):193. doi: 10.1186/s12877-018-0868-2.
- Background: PubMed 22841936Reijnders J, van Heugten C, van Boxtel M. Cognitive interventions in healthy older adults and people with mild cognitive impairment: a systematic review. Ageing Res Rev. 2013 Jan;12(1):263-75. doi: 10.1016/j.arr.2012.07.003. Epub 2012 Jul 25.
- Background: PubMed 17179457Willis SL, Tennstedt SL, Marsiske M, Ball K, Elias J, Koepke KM, Morris JN, Rebok GW, Unverzagt FW, Stoddard AM, Wright E; ACTIVE Study Group. Long-term effects of cognitive training on everyday functional outcomes in older adults. JAMA. 2006 Dec 20;296(23):2805-14. doi: 10.1001/jama.296.23.2805.
- Background: PubMed 10206606Heruti RJ, Lusky A, Barell V, Ohry A, Adunsky A. Cognitive status at admission: does it affect the rehabilitation outcome of elderly patients with hip fracture? Arch Phys Med Rehabil. 1999 Apr;80(4):432-6. doi: 10.1016/s0003-9993(99)90281-2.
- Individual participant dataSharing planned: No
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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.
Avital Hershkovitz, MD principal investigator
Rabin MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing specific cognitive intervention and conventional occupational therapy treatment in people with Hip Fracture and Rehabilitation, run by Rabin Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 11 Apr 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 Israel. 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 Avital Hershkovitz, MD (972522342123, avitalhe@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Independence Measure (FIM) (time frame: The change in the measure from randomization until the date of discharge, assessed up 3 months.). The study lists 3 primary outcomes in all. 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 NCT04626934, which also lists 23 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 11 Apr 2023.