The Relationship of Bone Mineral Density With Balance, Functional Ambulation and Falls in Stroke Patients

Stroke Patients Clinical Trial

Official title:

The Relationship of Bone Mineral Density With Balance, Functional Ambulation and Falls in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05207748
• Other study ID #: E1/1026/2020
• Status: Completed
• Start date: January 27, 2022
• Est. completion date: November 20, 2022

Study information

• Verified date: May 2024
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to investigate the relationship between bone mineral density and balance, functional ambulation and falls in hemiparetic patients with stroke in the subacute and chronic phases.

Description:

Improving balance function is considered as an important method for reducing the risk of falling after stroke and protecting bone health. Bone mineral density, a measure of bone health, has been reported to decrease after stroke, consistent with increased bone resorption and decreased bone formation. The aim of this study is to investigate the relationship between bone mineral density and balance, functional ambulation and falls in hemiparetic patients with stroke in the subacute and chronic phases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 20, 2022
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients = 50 and = 75 years old

• Patients with a 10-year risk of hip fracture =3%, major osteoporotic fracture risk =20% according to the Fracture Risk Assessment Tool, FRAX, scoring

• Patients with unilateral hemiplegia as a result of first-time stroke (onset time > 3 months)

• Patients who can stand for at least 2 minutes independently/under supervision for measurements while standing, and who can walk at least 10 meters independently/under supervision with or without walking aid for measurements taken while walking

• Patients whose cognitive status is able to understand the study instructions (Mini-Mental State Assessment score = 23)

• Patients with stable medical and psychological status

• Patients willing to participate in the study

Exclusion Criteria:

• Patients with serious cardiovascular or musculoskeletal problems that prevent walking

• Patients with severe vision, hearing and language problems

• Patients with other neurological (Parkinson's, epilepsy, meningitis, cerebellar disease, vertigo, dizziness, polyneuropathy, etc.) or musculoskeletal (severe low back pain, knee problems) diseases that may affect balance performance other than stroke.

• Patients with peripheral vascular disease

Related Conditions & MeSH terms

• Stroke
• Stroke Patients

Intervention

Diagnostic Test:
• Bone mineral density
Bone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA) method.

Locations

Country	Name	City	State
Turkey	Gaziler Physical Medicine and Rehabilitation Education and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density	Bone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA) method.	baseline
Secondary	Berg Balance Scale	The Berg Balance Scale is a widely used clinical test that can reveal a person's static and dynamic balance abilities. Total test score range from 0 (lowest balance) to 56 (highest balance) ability.	baseline
Secondary	Functional Ambulation Classification	The Functional Ambulation Classification is a functional walking test that evaluates ambulation ability. It includes six different categories and assesses ambulation status by determining how much support the patient needs while walking, regardless of whether they use assistive devices.	baseline
Secondary	Timed up and go test	The timed up and go test is a test used to evaluate mobility, balance, and walking in people with balance disorders.	baseline
Secondary	Falls Self-Efficacy Scale	The International Fall Activity Scale is a scale that examines an individual's concerns about the possibility of falling during 16 different activities that do not threaten daily life.The response option ranged from 1-4 depicted by 1 for being not at all concerned, 2 for being somewhat concerned, 3 for being fairly concerned and 4 for being very concerned.	baseline