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A time-matched randomized controlled trial of a powered hip exoskeleton with multimodal training in older sarcopenia adults

A time-matched randomized controlled trial of a powered hip exoskeleton with multimodal training in older sarcopenia adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125093
Enrollment
Unknown
Registered
2026-05-21
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Interventions

Test group:Dual-mode hip active assistive exoskeleton training (power-assisted walking + hip flexion-extension resistance training)
Control group:Routine geriatric exercise training

Sponsors

The First Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=50 years; 2. Meets the AWGS 2025 sarcopenia diagnostic framework, confirmed by low muscle strength (grip strength) and low muscle mass (measured by DXA or BIA); physical performance (5×STS, gait speed) will be recorded according to AWGS 2025 criteria as outcome measures for efficacy and prognosis analysis. 3. Physical performance: Baseline SPPB (0–12 points) will be recorded, and participants will be stratified by SPPB scores (e.g., SPPB 0–6 vs 7–9 vs 10–12) for randomization and subgroup analysis; SPPB score is not used as a diagnostic criterion for sarcopenia. 4. Frailty status: Fried phenotype score 1–3 (pre-frail/frail) or Clinical Frailty Scale (CFS) score 4–6 (mild-to-moderate frailty); CFS assessment will be completed by trained geriatricians/researchers. 5. Able to complete >=10 meters of indoor walking under supervision; 6. Signed informed consent obtained.

Exclusion criteria

Exclusion criteria: Participant-related factors: 1. Severe cognitive impairment with inability to cooperate with study procedures; 2. Participant deemed unsuitable for inclusion at the investigator’s discretion. Condition-related factors: 3. Recent acute cardiovascular or cerebrovascular events; 4. Unhealed fractures, or severe osteoporosis with recent fragility fractures; 5. Severe joint deformity or skin conditions preventing device wear; 6. Severe skin breakdown or open wounds in the device application area.

Design outcomes

Primary

MeasureTime frame
4-meter walking speed (m/s);

Secondary

MeasureTime frame
Change in Short Physical Performance Battery (SPPB) total score;5-times sit-to-stand test (5×STS);EuroQol Five-Dimensional Five-Level Health Questionnaire(EQ-5D-5L);Timed Up and Go test (TUG) completion time;Grip strength;6-minute walk test distance (6MWT);36-Item Short Form Health Survey (SF-36) quality of life score;Falls Efficacy Scale-International (FES-I) score;World Health Organization Five-Item Well-Being Index (WHO-5) score;Incidence of adverse events;

Countries

China

Contacts

Public ContactXu Zherong

The First Affiliated Hospital of Zhejiang University School of Medicine

xuzherong@yeah.net+86 135 1581 1193

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026