NCT06537791

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

July 31, 2024

Last Update Submit

August 19, 2024

Conditions

Keywords

Musculoskeletal DisabilitiesNeurological DisabilitiesBerg Balance ScaleBeck Depression InventoryMultidisciplinary RehabilitationHome-Based CarePhysical RehabilitationMental Health AssessmentFall Risk ReductionPatient-Centered Care

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

  • Changes in Depression Levels

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

Study Arms (1)

Home-Based Rehabilitation Program

EXPERIMENTAL

Participants 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.

Behavioral: Home-Based Rehabilitation Program

Interventions

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

Home-Based Rehabilitation Program

Eligibility Criteria

Age18 Years - 98 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corporación de Rehabilitación Club de Leones Cruz del Sur

Punta Arenas, Region of Magallanes, 6211525, Chile

Location

Related Publications (13)

  • 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.

    PMID: 17453984BACKGROUND
  • 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.

    PMID: 9793750BACKGROUND
  • 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.

    PMID: 10797161BACKGROUND
  • 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.

    PMID: 34747801BACKGROUND
  • 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.

    PMID: 33239179BACKGROUND
  • 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.

    PMID: 29099967BACKGROUND
  • 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.

    PMID: 35462312BACKGROUND
  • 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.

    PMID: 8650273BACKGROUND
  • 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.

    PMID: 25149678BACKGROUND
  • 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.

    PMID: 30547249BACKGROUND
  • 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.

    PMID: 36949431BACKGROUND
  • 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.

    PMID: 26122891BACKGROUND
  • 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.

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 5, 2024

Study Start

June 1, 2023

Primary Completion

December 8, 2023

Study Completion

December 8, 2023

Last Updated

August 21, 2024

Record last verified: 2024-08

Locations