NCT06476743

Brief Summary

Balance plays a significant role in stability and walking and it's essential for improving the quality of life and functional autonomy while reducing the risk of falling. This research intends to shed light on the advantages of sensory integration therapy and balance board training because it is important to addressing the issues related to ageing and their possible effects.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

February 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

June 11, 2024

Last Update Submit

June 24, 2024

Conditions

Geriatrics

Keywords

older adultsmobility limitationPostural balanceSensory

Outcome Measures

Primary Outcomes (1)

  • Berg Balance Scale

    Berg balance scale is used to find and access the balance issues. This scale consists of 14 task which related to everyday life. Each function rates from 0 (worst) to 4 (best) along a dependence and independence sequence. In this test, we gradually reduce the base of support from sitting and standing to single-leg stance, assess a subject's capacity to sustain positions or movements of increasing difficulty. One's ability to change position is also evaluated

    8th week

Secondary Outcomes (3)

  • Time up and go test

    8th week

  • Fall risk assessment tool

    8th week

  • Functional Reach Test

    8th week

Study Arms (2)

Sensory Integration Therapy

ACTIVE COMPARATOR

Sensory integration therapy in older adults focuses on optimizing sensory processing to enhance overall function and well-being. It aims to improve sensory perception, coordination, and integration, which are essential for maintaining balance and mobility

Other: Sensory Integration Therapy

Balance Board Training

ACTIVE COMPARATOR

Balance board training in older adults is a targeted approach aimed at enhancing stability and reducing fall risk. Utilizing specialized boards, it challenges balance control and proprioception, crucial for maintaining equilibrium. Through regular practice, older adults can improve muscle strength, coordination, and confidence in weight-bearing activities

Other: Balance Board Training

Interventions

Sensory Integration TherapyOTHER

This group will receive sensory integration therapy for 30 minutes along with routine physical therapy treatment (warm up exercises and Stretching exercises (hamstrings, quadriceps, and calf muscles) for 15 minutes per session for 3 days a week for 8 week.

Sensory Integration Therapy
Balance Board TrainingOTHER

This group will receive balance board training for 30 minutes along with routine physical therapy treatment (warm up exercises and Stretching exercises (hamstrings, quadriceps, and calf muscles) for 15 minutes per session for 3 days a week.

Balance Board Training

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Should be living independently (FIM 108-126).
  • No history of lower limb injury in the 1 year prior to the study.
  • Individuals with MMSE score greater than or equal to 24.
  • Individuals with BBS score 41-56.

You may not qualify if:

  • Individuals with recent cardiac or neurological changes in medical status.
  • Individuals with recent surgical procedures within the last 6 months will not include in the study.
  • Individuals with the presence of inner ear problems, dizziness, long-term medication.
  • A history of injury within 1 year before the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Al-Shifa Malik Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Gosha e Shifa Hosital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (6)

  • Thompson LA, Savadkoohi M, de Paiva GV, Augusto Renno Brusamolin J, Guise J, Suh P, Guerrero PS. Sensory integration training improves balance in older individuals. Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul;2020:3811-3814. doi: 10.1109/EMBC44109.2020.9175715.

    PMID: 33018831BACKGROUND

  • Yousefi Babadi S, Daneshmandi H. Effects of virtual reality versus conventional balance training on balance of the elderly. Exp Gerontol. 2021 Oct 1;153:111498. doi: 10.1016/j.exger.2021.111498. Epub 2021 Jul 24.

    PMID: 34311059BACKGROUND

  • Zouita S, Zouhal H, Ferchichi H, Paillard T, Dziri C, Hackney AC, Laher I, Granacher U, Ben Moussa Zouita A. Effects of Combined Balance and Strength Training on Measures of Balance and Muscle Strength in Older Women With a History of Falls. Front Physiol. 2020 Dec 23;11:619016. doi: 10.3389/fphys.2020.619016. eCollection 2020.

    PMID: 33424642BACKGROUND

  • Bao T, Carender WJ, Kinnaird C, Barone VJ, Peethambaran G, Whitney SL, Kabeto M, Seidler RD, Sienko KH. Effects of long-term balance training with vibrotactile sensory augmentation among community-dwelling healthy older adults: a randomized preliminary study. J Neuroeng Rehabil. 2018 Jan 18;15(1):5. doi: 10.1186/s12984-017-0339-6.

    PMID: 29347946BACKGROUND

  • Golla A, Muller T, Wohlfarth K, Jahn P, Mattukat K, Mau W. Home-based balance training using Wii Fit: a pilot randomised controlled trial with mobile older stroke survivors. Pilot Feasibility Stud. 2018 Aug 25;4:143. doi: 10.1186/s40814-018-0334-0. eCollection 2018.

    PMID: 30155268BACKGROUND

  • de Vries AW, Faber G, Jonkers I, Van Dieen JH, Verschueren SMP. Virtual reality balance training for elderly: Similar skiing games elicit different challenges in balance training. Gait Posture. 2018 Jan;59:111-116. doi: 10.1016/j.gaitpost.2017.10.006. Epub 2017 Oct 5.

    PMID: 29028622BACKGROUND

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hira Jabeen

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hira Jabeen

CONTACT

03234116506hira.jabeen@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 26, 2024

Study Start

February 1, 2024

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

June 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)