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Clinical Efficacy of Exoskeleton Robot-Assisted Rehabilitation on Lower Limb Functional Recovery in Elderly Patients with Hip Fracture: A Multicenter, Open-Label, Randomized Controlled Clinical Trial

Clinical Efficacy of Exoskeleton Robot-Assisted Rehabilitation on Lower Limb Functional Recovery in Elderly Patients with Hip Fracture: A Multicenter, Open-Label, Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113566
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Hip Fracture

Interventions

Intervention Group:1. Postural Adaptation Training: With exoskeleton support, the patient transitions from a lying or sitting position to an upright stance and maintains this posture for a prescribed
Control Group:1. Based on the patients general condition and baseline status, ankle pumps, and isometric contractions of the quadriceps and gluteus medius will be performed progressively according to
followed by initiation of knee extension exercises, hip abduction exercises of the affected limb, and bridge exercises
2. Once the patients physical capacity has recovered to a relatively stable level, progressive resistance training for the quadriceps, hamstrings, and gluteal muscles will be gradually introduced, alo
3. Depending on the patients rehabilitation progress, training in position transfer, standing, and gait will be initiated
traditional physical rehabilitation modalities such as therapeutic cycling, electrical stimulation, and medium-frequency therapy devices may also be incorporated.

Sponsors

Beijing Jishuitan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=65 years, regardless of gender 2. Diagnosed with unilateral hip fracture due to low-energy trauma by imaging (X-ray/CT), and having completed surgical treatment (internal fixation or arthroplasty) 3. The participant or legal guardian understands and agrees to participate in the clinical trial, and willing to provide voluntary written informed consent

Exclusion criteria

Exclusion criteria: 1. Life expectancy 100 kg); 5. Height outside the adjustable range of the device; 6. Presence of a pathological fracture or multiple fragility fractures; 7. Presence of severe osteoarthritis or trauma in the contralateral lower limb that significantly impairs function; 8. Comorbidities including active malignancy or systemic infection; 9. Comorbidities such as thromboembolic disease in the lower limbs, pneumonia, or pressure injuries (bedsores); 10. Comorbidities affecting rehabilitation capacity, including unstable angina, heart failure, severe sequelae of stroke, severe chronic obstructive pulmonary disease (COPD), or severe hepatic/renal dysfunction; 11. Poor compliance, cognitive impairment preventing cooperation, or diagnosed psychiatric disorders such as depression or anxiety; 12. Participation in any other clinical trial within 3 months prior to screening.

Design outcomes

Primary

MeasureTime frame
Harris Hip Score;

Secondary

MeasureTime frame
Timed Up and Go Test;6-Minute Walk Test;Berg Balance Scale;Range of Motion Measurement;Psychological Assessment;Proteomic Analysis;Visual Analogue Scale;

Countries

China

Contacts

Public ContactHai Bao

Beijing Jishuitan Hospital, Capital Medical University

haibao@bjmu.edu.cn+86 188 1179 2909

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026