Cognitive Intervention and Rehabilitation Outcomes in Hip Fracture Patients

NCT04626934 | Unknown

• 1 other identifier: 0465-20-RMC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the present study is to assess whether specific cognitive intervention will influence rehabilitation outcomes of post-acute hip fracture patients.

Conditions

Hip Fracture; Rehabilitation; Cognitive Intervention

Keywords

cognitive; Intervention; Hip fracture; Rehabilitation; outcomes

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

  The score will be calculated at discharge, assessed up to 3 months from randomization.

Secondary Outcomes (5)

• Color Trail Test

  The change in the measure from admission and upon completion of the intervention protocol (3 weeks).

• Kettle Test

  The change in the measure from admission and upon completion of the intervention protocol (3 weeks).

• Groningen Activity Restriction Scale

  The change in the measure from admission and upon completion of the intervention protocol (3 weeks).

• Montreal Cognitive Assessement (MOCA)

  The change in the measure from admission and upon completion of the intervention protocol (3 weeks).

• EQ-5D (EuroQol Group)

  The change in the measure from admission and upon completion of the intervention protocol (3 weeks).

Study Arms (2)

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.

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.

Other: specific cognitive intervention

Interventions

specific cognitive intervention OTHER

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.

Intervention group

conventional occupational therapy treatment OTHER

The intervention will include all together 12 sessions of conventional occupational therapy treatments, each being 45 minutes, for a total of 3 weeks.

control group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead
• Tel Aviv University: collaborator

Study Sites (1)

"Beit- Rivka" geriatric rehabilitation hospital

Petach Tiqva, Israel

RECRUITING

Related Publications (23)

• 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.

  BACKGROUND

• 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.

  PMID: 30454790 BACKGROUND

• Beloosesky 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.

  PMID: 12017519 BACKGROUND

• Rolland 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.

  PMID: 15204479 BACKGROUND

• Gruber-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.

  PMID: 28176306 BACKGROUND

• Mizrahi 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.

  PMID: 30006209 BACKGROUND

• Ball 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.

  PMID: 12425704 BACKGROUND

• Lipardo 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.

  PMID: 32380917 BACKGROUND

• Lipardo 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.

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  PMID: 22841936 BACKGROUND

• Willis 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.

  PMID: 17179457 BACKGROUND

• Heruti 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.

  PMID: 10206606 BACKGROUND

• Hamilton 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.

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• 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.

  PMID: 8305182 BACKGROUND

• Hartman-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.

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  PMID: 21558283 BACKGROUND

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MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Avital Hershkovitz, MD

  Rabin MC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Avital Hershkovitz, MD

CONTACT

972522342123; avitalhe@clalit.org.il

Yedida Borow, BOT

CONTACT

072546441838; yedidabo@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients and the team that assess the patients do not know to which group the patients have been assigned
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Geriatric Rehabilitation Ward

Model Details: Randomized double blinded study

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 13, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)