Comparison of Otago and Beat it Program on Balance, Gait and QOL in Diabetic Neuropathy
4 maj 2026 uppdaterad av: Riphah International University
Comparative Effects of Otago Exercise Program and Beat it Program on Balance, Gait and Quality of Life in Patients With Diabetic Peripheral Neuropathy
this study aims to compare the effects of Otago exercise program and BEAT IT program on balance, gait and quality of life in patients with diabetic peripheral neuropathy.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Limited studies have been conducted to assess gait and quality of life.
Most of the studies related to the Otago exercise program conducted in the geriatric population, stroke, Parkinson's, alcoholic neuropathy, chronic inflammatory polyneuropathy, and so on, a few studies conducted on diabetes, however up to the researcher's knowledge its effect on diabetic neuropathy has not been found.
Similarly, studies related to the BEAT IT Program conducted in cancer patients and diabetes populations.
Hence there is a need for comparative study on Otago exercise program and BEAT IT program to assess balance, gait and quality of life in patients with diabetic peripheral neuropathy
Studietyp
Interventionell
Inskrivning (Beräknad)
32
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Muneeb Khan, PhD
- Telefonnummer: +92336799611
- E-post: muneeb.khan@riphah.edu.pk
Studieorter
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54500
- THQ hospital
-
Kontakt:
- Javeria Ghazal, MS
- Telefonnummer: +923335154664
- E-post: javeria.ghazal@riphah.edu.pk
-
Huvudutredare:
- Sania Hassan, MS
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- physician-diagnosed type 2 diabetes, with peripheral neuropathy (defined by Michigan Neuropathy Screening Instrument questionnaire score of 5 or greater) the ability to walk independently for 20 m (97).
- Having score between 46 to 52 (out of a total of 56 points) on the BBS
Exclusion Criteria:
- fracture of the lower limb within the 6 months before the study
- diabetic ulcer, infection or partial amputation in feet
- disease or functional impairment of auditory, vestibular system
- Dementia or inability to give consistent information
- History of surgical procedure at the knee, ankle, or hip or indication of surgery throughout the intervention period malignancy, other neurological or orthopedic impairments (such as stroke, poliomyelitis, rheumatoid arthritis, prosthesis, or severe osteoarthritis), major vascular complications (venous or arterial ulcers), severe retinopathy, or severe nephropathy that causes edema or needs hemodialysis
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Otago program
Participants performed a combination of warm-up, strengthening, balance, and aerobic exercises at home.
|
The program included: 5 Strengthening exercises and 12 balance exercises. 30-40 min, 4x/week for 8 weeks. Balance Exercises: Knee bends Backwards walking Walking and turning around Sideways walking Tandem stance (heel toe stance) Tandem walk (heel toe walk) One leg stance Heel walking Toe walk Heel toe walking backwards Sit to stand Stair walking Strength exercises: Knee extensor Knee flexor Hip adductor Ankle planter flexors (calf raises) Ankle dorsiflexors (toe raises) |
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Experimentell: BEAT it program
Participants performed moderate-intensity aerobic, resistance, balance, and flexibility exercises, along with education on diabetes self-management.
The exercises were designed to be completed at home using minimal equipment or household items
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Strengthening exercises Toe spreading Ankle pump Mini wall squats Slow march in standing Knee with pillow press up Bridging Step up and down on stair 1st step Toe curls Stretching Hamstring stretch Dorsiflexors and planter flexors stretch Quads stretch Biceps stretch Triceps stretch Balance exercises Leg front and back swinging Weight shifting front and back Leg sideways Sideway alternate step Tandem stand Alternate heel toe raises Sessions were performed;
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
4 Stage Balance Test
Tidsram: 8th week
|
The Four Stage Balance Test is a validated measure recommended to evaluate static balance. Four standing positions get progressively harder to maintain.
|
8th week
|
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Mini BESTest
Tidsram: 8th week
|
This test measures dynamic balance, functional mobility, and gait.
The Mini-BESTest, the shortened form of BESTest, contains only 14 different tasks and involves four sub-sections: anticipatory postural adjustments, postural response to external perturbations, sensory orientation, and stability in gait.
Two items of Mini-BESTest are assessed bilaterally, but only the lower score was added to the maximum score of 28 points, which results from grading based on a 3-point ordinal scale ranging from 0 (severe balance impairment) to 2 (no balance impairment) (108).
Reliability 0.98; Validity 0.65.
|
8th week
|
|
Functional Reach Test
Tidsram: 8th week
|
FRT is used to evaluate anticipatory balance which correlates with fall risks.
This test measures the margin of stability along with the ability to measure balance during a functional task.
Reliability 0.89; Sensitivity 76%; Specificity 34%
|
8th week
|
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Functional Gait Assessment
Tidsram: 8th week
|
The FGA has been validated for the assessment of balance in people with vestibular dysfunction, community-dwelling older adults, patients with stroke, and patients with Parkinson disease.
The FGA has good reliability (interrater reliability: intraclass correlation coefficient [ICC]=.74;
interrater reliability: ICC=.86 to .93) and internal consistency (Cronbach alpha=.79)
|
8th week
|
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Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) questionnaire
Tidsram: 8th week
|
The Norfolk Quality-of Life Diabetic Neuropathy tool (QOL-DN) has been found to be reliable across many different populations.
This comprehensive tool has demonstrated sensitivity to both small and large fiber impairment while also detecting improvements in neuropathy.
Intra class Reliability >0.9; Internal Consistency >0.6
|
8th week
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Javeria Ghazal, MS, Riphah International University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
15 maj 2026
Primärt slutförande (Beräknad)
30 augusti 2026
Avslutad studie (Beräknad)
15 september 2026
Studieregistreringsdatum
Först inskickad
23 februari 2026
Först inskickad som uppfyllde QC-kriterierna
4 maj 2026
Första postat (Faktisk)
8 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- REC/RCR &AHS/24/0296
Plan för individuella deltagardata (IPD)
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NEJ
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