- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07717034
Effects of Sensory Integration Training on Static Standing Balance in Older Adults
Balance impairment is a common problem among adults aged 60 years and older due to age-related decline in the visual, vestibular, and somatosensory systems. These impairments increase the risk of falls, reduce mobility, and compromise functional independence and quality of life. Conventional balance training is commonly used to improve postural stability; however, the additional benefits of sensory integration training remain unclear.
This randomized controlled trial aims to evaluate the effect of sensory integration training combined with conventional balance training on static standing balance in older adults with a moderate risk of falls. Twenty-eight participants aged 60 years and above will be recruited and randomly allocated into an experimental group (n=14) and a control group (n=14). Experimental group will receive sesnory integration training and control group will receive conventional balance training three times per week for six weeks.
Balance performance will be assessed before and after the intervention using the Berg Balance Scale (BBS), Balance Error Scoring System (BESS), and Modified Clinical Test of Sensory Interaction on Balance (mCTSIB). Data will be analyzed using paired-sample t-tests for within-group comparisons and independent-sample t-tests for between-group comparisons. Statistical significance will be set at p<0.05.
Studienübersicht
Status
Detaillierte Beschreibung
Balance impairment is one of the leading causes of falls among older adults and is associated with reduced mobility, impaired postural control, functional dependence, and decreased quality of life. Aging results in progressive deterioration of the visual, vestibular, and somatosensory systems, reducing the ability to effectively integrate sensory information required for maintaining balance. Consequently, older adults become increasingly vulnerable to falls and fall-related injuries.
Conventional balance training is widely used in rehabilitation to improve postural stability. Sensory integration training is an intervention that specifically challenges the central nervous system to effectively process and reweight sensory information from visual, vestibular, and somatosensory inputs under different environmental conditions. Although previous studies have demonstrated improvements in balance following sensory integration training, evidence regarding its additional benefit over conventional balance training remains limited.
This randomized controlled trial aims to evaluate the effectiveness of sensory integration training combined with conventional balance training in improving static standing balance among older adults with a moderate risk of falls.
Twenty-eight participants aged 60 years or older who meet the eligibility criteria will be enrolled after providing written informed consent. Participants will be randomly allocated into either an experimental group (n=14) or a control group (n=14) using simple randomization. Experimental groups will receive sensory integration training and control group will receive conventional balance training for six weeks, with three treatment sessions per week.
Outcome assessments will be conducted at baseline and immediately after completion of the six-week intervention. Static standing balance will be evaluated using the Berg Balance Scale (BBS), Balance Error Scoring System (BESS), and Modified Clinical Test of Sensory Interaction on Balance (mCTSIB). These validated outcome measures will assess functional balance, postural stability, and sensory integration during standing.
Balance impairment is one of the leading causes of falls among older adults and is associated with reduced mobility, impaired postural control, functional dependence, and decreased quality of life. Aging results in progressive deterioration of the visual, vestibular, and somatosensory systems, reducing the ability to effectively integrate sensory information required for maintaining balance. Consequently, older adults become increasingly vulnerable to falls and fall-related injuries.
Conventional balance training is widely used in rehabilitation to improve postural stability. Sensory integration training is an intervention that specifically challenges the central nervous system to effectively process and reweight sensory information from visual, vestibular, and somatosensory inputs under different environmental conditions. Although previous studies have demonstrated improvements in balance following sensory integration training, evidence regarding its additional benefit over conventional balance training remains limited.
This randomized controlled trial aims to evaluate the effectiveness of sensory integration training combined with conventional balance training in improving static standing balance among older adults with a moderate risk of falls.
Twenty-eight participants aged 60 years or older who meet the eligibility criteria will be enrolled after providing written informed consent. Participants will be randomly allocated into either an experimental group (n=14) or a control group (n=14) using simple randomization. Both groups will receive conventional balance training for six weeks, with three treatment sessions per week. In addition, the experimental group will receive sensory integration training consisting of progressively challenging balance exercises performed under altered visual, vestibular, and somatosensory conditions.
Outcome assessments will be conducted at baseline and immediately after completion of the six-week intervention. Static standing balance will be evaluated using the Berg Balance Scale (BBS), Balance Error Scoring System (BESS), and Modified Clinical Test of Sensory Interaction on Balance (mCTSIB). These validated outcome measures will assess functional balance, postural stability, and sensory integration during standing.
Statistical analyses will be performed using SPSS software. Descriptive statistics will summarize participant characteristics. Data normality will be assessed prior to inferential analysis. Paired-sample t-tests will be used to compare pre- and post-intervention outcomes within each group, while independent-sample t-tests will compare changes between groups. Statistical significance will be established at a p-value of less than 0.05.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Islamabad, Pakistan, 44000
- Foundation University College of Physical Therapy
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Age above 60.
- Both Genders.
- Able to understand and follow command.
- Berg balance score lies between 21-40.
Exclusion Criteria:
- Diagnosed vestibular and neurological conditions.
- Orthopedic Conditions i.e., Recent fractures or surgeries, cervical spine issues or severe OA
- Severe visual or auditory deficit
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Sensory Integration Training
Participants completed three supervised sessions per week following the same static balance progression: standing on both feet, feet side by side, tandem stance, and single-leg stance. Week 1: Static balance exercises on a firm surface. Week 2: Session 1: standard training; Session 2: auditory deprivation; Session 3: visual deprivation with verbal cues. Week 3: Static balance on a sandy surface while wearing comfortable footwear with normal visual and auditory input. Week 4: Session 1: standard training; Session 2: combined auditory and visual deprivation; Session 3: visual deprivation with verbal cues. Week 5: Session 1: standard training; Sessions 2-3: progressive shoulder-tap somatosensory perturbations with safety monitoring. Week 6: Static balance on sand with comfortable footwear. Session 1: visual and auditory deprivation; Session 2: auditory deprivation with picture cues and shoulder taps; Session 3: visual deprivation with verbal cues and shoulder taps |
The experimental group participated in a structured six-week intervention program consisting exclusively of sensory integration training.
Participants attended three supervised sessions per week.
Each session included three repetitions of the exercises, with participants allowed a rest period of 30 to 60 seconds between repetitions to prevent fatigue and maintain the quality of each movement.
Over the entire six-week period, participants completed a total of 18 supervised sessions.
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Sonstiges: Conventional Balance training
Conventional Balance Training (6 Weeks): Participants attended three supervised sessions per week. Each session included sitting, standing, weight-shifting, gait, and functional balance activities with progressive difficulty. Week 1: Sitting with legs uncrossed, stepping forward/backward/sideways, and ball control while sitting then standing. Week 2: Sitting with legs crossed, marching in place, and head rotations (up/down) during standing and walking. Week 3: Normal standing, reaching tasks in sitting and standing, and trunk rotations during sitting, standing, and walking. Week 4: Tandem stance, picking up objects from a table, stool, and floor, and walking forward, backward, and sideways. Weeks 5-6: Single-leg stance, standing on foam, and dual-task training, including standing while holding a ball over a book and catching a ball, to improve postural control, coordination, and functional balance. |
The control group participated in a structured six-week intervention program consisting exclusively of conventional balance training.
Participants attended three supervised sessions per week.
Each session included three repetitions of the exercises, with participants allowed a rest period of 30 to 60 seconds between repetitions to prevent fatigue and maintain the quality of each movement.
Over the entire six-week period, participants completed a total of 18 supervised sessions.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Balance
Zeitfenster: 6 weeks
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The Berg balance scale serves to objectively evaluate a patient's capacity to maintain safe equilibrium throughout a sequence of standardized activities. It comprises 14 components, with each component featuring five levels of scoring ranging from 0 to 4. Score range between 0-56. 0-20 means significant balance problems 21-40 moderate balance problem 41-56 independent with good balance |
6 weeks
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Balance
Zeitfenster: 6 weeks
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The balance error scoring system was used. Score ranges:
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6 weeks
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Balance
Zeitfenster: 6 weeks
|
Modified Clinical Test of Sensory Interaction on Balance was used Score Ranges:
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6 weeks
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- FUI/CTR/2025/28
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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