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Musculoskeletal DiseasesHB-RehabNCT06537791

Impact of Home-Based Rehabilitation on Motor Function and Mood in Individuals With Disabilities

A study testing Home-Based Rehabilitation Program in people with Musculoskeletal Diseases and Neurological Diseases, run by Corporación de Rehabilitación Club de Leones Cruz del Sur at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate the impact of a multidisciplinary home-based rehabilitation program on motor function and mood in individuals with moderate neuromusculoskeletal disabilities. Read more about this study

Who is it for?
Ages 18 to 98 years
What is being tested?
Home-Based Rehabilitation Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
1 siteChile
Study dates
1 Jun 2023to 8 Dec 2023
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 18 to 98 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals with moderate neuromusculoskeletal disabilities.
  • Participants referred by recognized medical institutions.
  • Able to provide informed consent.

Who cannot join

  • Individuals with severe cognitive impairments that hinder their ability to follow the rehabilitation program.
  • Participants with acute medical conditions that require immediate hospitalization.
  • Pregnant women.

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Corporación de Rehabilitación Club de Leones Cruz del Sur

    Punta Arenas, Region of Magallanes, 6211525

Other trials in Chile

About this study

Official title: Multidisciplinary Home-Based Rehabilitation Program for Individuals With Disabilities: A Retrospective Study

This study aims to evaluate the impact of a multidisciplinary home-based rehabilitation program on motor function and mood in individuals with moderate neuromusculoskeletal disabilities. Participants will receive personalized treatment plans over four months, including sessions in physical therapy, occupational therapy, nutrition, psychology, nursing, and podiatry. The study will measure motor function using the Berg Balance Scale and mood using the Beck Depression Inventory. This program will be conducted in the Magallanes region of Chile, involving participants recruited from the National Disability Registry.

Read the detailed description

This study is designed to assess the effectiveness of a comprehensive home-based rehabilitation program for individuals with moderate neuromusculoskeletal disabilities. The intervention will include a multidisciplinary approach, involving a team of healthcare professionals who will provide a range of services tailored to each participant's needs. The services will include 32 sessions of physical therapy, 8 sessions of occupational therapy, 4 sessions of nutrition counseling, 8 sessions of psychological support, and 4 sessions of nursing and podiatry care. The intervention will span four months, with a total of 82 hours of therapy per participant.

Participants will be evaluated at the beginning and end of the program using the Berg Balance Scale to measure motor function and the Beck Depression Inventory to assess mood. The study aims to demonstrat improvements in motor function and balance, with a reduction in fall risk, and to explore changes in depression levels among the participants.

Quality assurance procedures will include standardized training for all healthcare professionals involved, regular monitoring of therapy sessions, and adherence to established protocols for data collection and analysis. This study highlights the potential benefits of home-based rehabilitation programs and underscores the need for further research to explore long-term outcomes and additional measures to enhance patient well-being.

Being tested
Home-Based Rehabilitation Program
Keywords
Musculoskeletal Disabilities, Neurological Disabilities, Berg Balance Scale, Beck Depression Inventory, Multidisciplinary Rehabilitation, Home-Based Care, Physical Rehabilitation, Mental Health Assessment, Fall Risk Reduction, Patient-Centered Care
Medical subject headings
Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-Based Rehabilitation ProgramBehavioural

    Physical Therapy: 32 sessions, 60 minutes each Occupational Therapy: 8 sessions, 60 minutes each Nutrition Counseling: 4 sessions, 60 minutes each Psychological Support: 8 sessions, 60 minutes each Nursing and Podiatry Care: 4 sessions, 60 minutes each Total Duration: Approximately 4 months

Study groups in NCT06537791
Study groupRoleWhat they receive
Home-Based Rehabilitation ProgramExperimentalParticipants in this arm will receive a multidisciplinary home-based rehabilitation program. The intervention includes 32 sessions of physical therapy, 8 sessions of occupational therapy, 4 sessions of nutrition counseling, 8 sessions of psychological support, and 4 sessions of nursing and podiatry care. Each session lasts 60 minutes, and the total duration of the intervention is approximately 4 months. The program aims to improve motor function, balance, and mood among individuals with moderate neuromusculoskeletal disabilities.
Receives: Behavioral: Home-Based Rehabilitation Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in Motor Function

    Assessment of the improvement in motor function of the participants, measured using the Berg Balance Scale. This scale assesses balance through 14 common tasks performed in daily life. Scores range from 0 to 56 points, where 0 indicates a low level of balance and 56 indicates an excellent level of balance. A higher score on this scale represents a better outcome in terms of balance and motor function.

    Measured: From study start to the end of the intervention (4 months).

Secondary outcomes (1)

  1. Changes in Depression Levels

    Assessment of changes in the participants' depression levels, measured using the Beck Depression Inventory. This inventory is a 21-item questionnaire that assesses the severity of depression. Scores can range from 0 to 63 points, with higher scores indicating a greater level of depression. Therefore, a higher score on this scale reflects a worse outcome in terms of emotional well-being.

    Measured: From study start to the end of the intervention (4 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2024
  2. Study start1 Jun 2023
  3. Primary completion8 Dec 2023
  4. Study completion8 Dec 2023

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06537791
Sponsor's protocol ID
CorporacionRCLCS0020
Acronym
HB-Rehab
Status last verified
Aug 2024
First submitted
31 Jul 2024
Last updated
21 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dow B, Black K, Bremner F, Fearn M. A comparison of a hospital-based and two home-based rehabilitation programmes. Disabil Rehabil. 2007 Apr 30;29(8):635-41. doi: 10.1080/09638280600902760.

    PubMed 17453984

  • von Koch L, Wottrich AW, Holmqvist LW. Rehabilitation in the home versus the hospital: the importance of context. Disabil Rehabil. 1998 Oct;20(10):367-72. doi: 10.3109/09638289809166095.

    PubMed 9793750

  • Anderson C, Rubenach S, Mhurchu CN, Clark M, Spencer C, Winsor A. Home or hospital for stroke rehabilitation? results of a randomized controlled trial : I: health outcomes at 6 months. Stroke. 2000 May;31(5):1024-31. doi: 10.1161/01.str.31.5.1024.

    PubMed 10797161

  • Saggini R, Veraldi R, Carmignano SM, Palermo T, Russo C, Barassi G, Bellomo RG. Home Rehabilitation System in Chronic Stroke: An Observational Study in Central Italy. Neurol India. 2021 Sep-Oct;69(5):1285-1292. doi: 10.4103/0028-3886.329548.

    PubMed 34747801

  • Bickenbach J, Sabariego C, Stucki G. Beneficiaries of Rehabilitation. Arch Phys Med Rehabil. 2021 Mar;102(3):543-548. doi: 10.1016/j.apmr.2020.09.392. Epub 2020 Oct 22.

    PubMed 33239179

  • Jette AM. The Importance of Dose of a Rehabilitation Intervention. Phys Ther. 2017 Nov 1;97(11):1043. doi: 10.1093/ptj/pzx085. No abstract available.

    PubMed 29099967

  • Li G, Li X, Chen L. Personally tailored exercises for improving physical outcomes for older adults in the community: A systematic review. Arch Gerontol Geriatr. 2022 Jul-Aug;101:104707. doi: 10.1016/j.archger.2022.104707. Epub 2022 Apr 19.

    PubMed 35462312

  • Bogle Thorbahn LD, Newton RA. Use of the Berg Balance Test to predict falls in elderly persons. Phys Ther. 1996 Jun;76(6):576-83; discussion 584-5. doi: 10.1093/ptj/76.6.576.

    PubMed 8650273

  • Mat S, Tan MP, Kamaruzzaman SB, Ng CT. Physical therapies for improving balance and reducing falls risk in osteoarthritis of the knee: a systematic review. Age Ageing. 2015 Jan;44(1):16-24. doi: 10.1093/ageing/afu112. Epub 2014 Aug 22.

    PubMed 25149678

  • Hamed A, Bohm S, Mersmann F, Arampatzis A. Follow-up efficacy of physical exercise interventions on fall incidence and fall risk in healthy older adults: a systematic review and meta-analysis. Sports Med Open. 2018 Dec 13;4(1):56. doi: 10.1186/s40798-018-0170-z.

    PubMed 30547249

  • Yalew ES, Melese AZ, Guadie YG, Abich Y, Kassa T, Gashaw M. Magnitude of depression and associated risk factors among patients with musculoskeletal disorder treated in physiotherapy outpatient department in Amhara region comprehensive specialized hospital in Ethiopia: a prospective cross-sectional study. BMC Psychiatry. 2023 Mar 22;23(1):189. doi: 10.1186/s12888-023-04658-3.

    PubMed 36949431

  • Bruijniks SJ, Bosmans J, Peeters FP, Hollon SD, van Oppen P, van den Boogaard M, Dingemanse P, Cuijpers P, Arntz A, Franx G, Huibers MJ. Frequency and change mechanisms of psychotherapy among depressed patients: study protocol for a multicenter randomized trial comparing twice-weekly versus once-weekly sessions of CBT and IPT. BMC Psychiatry. 2015 Jun 30;15:137. doi: 10.1186/s12888-015-0532-8.

    PubMed 26122891

  • Barria P, Andrade A, Gomez-Vargas D, Yelincic A, Roberti F, Bahamonde E, Aguilar R, Cordova B. Multidisciplinary Home-Based Rehabilitation Program for Individuals With Disabilities: Longitudinal Observational Study. JMIR Rehabil Assist Technol. 2024 Oct 16;11:e59915. doi: 10.2196/59915.

    PubMed 39412860

Questions about this trial

What is this clinical trial studying?

A study testing Home-Based Rehabilitation Program in people with Musculoskeletal Diseases and Neurological Diseases, run by Corporación de Rehabilitación Club de Leones Cruz del Sur at 1 site in Chile.

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 3 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 21 Aug 2024. 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 Chile. 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?

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?

Improvement in Motor Function (time frame: From study start to the end of the intervention (4 months).). 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 NCT06537791, which also lists 13 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 21 Aug 2024.

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