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Enrolling by Invitation

NCT Number: NCT07323147

Clinical Efficacy of Exoskeleton Robot-Assisted Rehabilitation on Lower Limb Functional Recovery in Elderly Patients With Hip Fracture

With the intensification of population aging, hip fracture, as a common bone disease, is seeing an increasing incidence rate among the elderly population. Traditional rehabilitation training methods can no longer fully meet the functional recovery needs of elderly patients with hip fractures. Due to their wearability and intelligence, exoskeleton robots provide an innovative solution for rehabilitation training. This study aims to explore the application effects of exoskeleton robots in postoperative rehabilitation for elderly patients with hip fractures by utilizing exoskeleton robot-assisted rehabilitation training for elderly hip surgery patients. The focus is on its improvements in motor ability, balance ability, and pain levels, while also assessing its impact on patients' overall quality of life and the prevention of complications.

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Key information

Conditions

Hip Fracture Femoral Fractures Fractures, Bone Gait Disorders Geriatrics Hip Fractures Hip Injuries Leg Injuries Lower Extremity Dysfunction Mobility Limitation Pathological Conditions, Signs and Symptoms Postoperative Rehabilitation Signs and Symptoms Wounds and Injuries

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Jishuitan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100035, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 65 years or older, regardless of gender.
  • Diagnosed with a unilateral hip fracture resulting from low-energy trauma by imaging (X-ray/CT), and having undergone surgical treatment (internal fixation or arthroplasty).
  • The participant or their legal guardian understands and agrees to participate in the clinical trial and is willing to provide voluntary written informed consent.

Exclusion criteria

  • Life expectancy of less than 6 months.
  • History of neurological disorders such as prior stroke, spinal cord injury, Parkinson's disease, or myasthenia gravis.
  • Severe joint contractures, deformities, or heterotopic ossification in the lower limbs that would prevent proper device fitting.
  • Body weight exceeding the device's maximum load capacity (>100 kg).
  • Height outside the adjustable range of the device.
  • Presence of a pathological fracture or multiple fragility fractures.
  • Presence of severe osteoarthritis or trauma in the contralateral lower limb that significantly impairs function.
  • Comorbidities including active malignancy or systemic infection.
  • Comorbidities such as thromboembolic disease in the lower limbs, pneumonia, or pressure injuries (bedsores).
  • Comorbidities affecting rehabilitation capacity, including unstable angina, heart failure, severe sequelae of stroke, severe chronic obstructive pulmonary disease (COPD), or severe hepatic/renal dysfunction.
  • Poor compliance, cognitive impairment preventing cooperation, or diagnosed psychiatric disorders such as depression or anxiety.
  • Participation in any other clinical trial within the 3 months prior to screening.

Treatment and study plan

Exoskeleton

Device
  • 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 duration.
  • Range of Motion (ROM) and Flexibility Training: The robot guides the patient's lower limbs (hip, knee, and ankle joints) through passive, large-amplitude flexion and extension movements within a safe range.
  • Muscle Reactivation and Low-Intensity Strengthening: With robotic assistance, the patient actively attempts to execute joint flexion and extension movements. The exoskeleton provides adjustable assistance levels proportionate to the patient's muscular capacity.

conventional rehabilitation program

Other
  • Based on the patient's general condition and baseline status, ankle pumps, and isometric contractions of the quadriceps and gluteus medius will be performed progressively according to current international and domestic rehabilitation guidelines; followed by initiation of knee extension exercises, hip abduction exercises of the affected limb, and bridge exercises;
  • Once the patient's physical capacity has recovered to a relatively stable level, progressive resistance training for the quadriceps, hamstrings, and gluteal muscles will be gradually introduced, along with concurrent strength training for both upper limbs and the unaffected lower limb;
  • Depending on the patient's 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.

Primary outcomes

  1. Harris Hip Score

    Time frame: 1-month post-intervention (T1), 3-month post-intervention (T2).

    Assessed using the Harris Hip Score (HHS), a disease-specific instrument widely used for evaluating outcomes following hip surgery or in hip pathology. The scale assesses the patient across four domains: pain (44 points), function (47 points), range of motion (5 points), and absence of deformity (4 points). The total score ranges from 0 to 100 points. A higher score indicates better hip joint function and less disability. The reported value is the total HHS score (points).

Secondary outcomes

  1. Berg Balance Scale

    Time frame: 1-month post-intervention (T1), 3-month post-intervention (T2)

    Assessed using the Berg Balance Scale. This scale consists of 14 items that evaluate static and dynamic balance abilities (e.g., standing, turning, picking up objects). Each item is scored from 0 to 4 points. The total score ranges from 0 to 56 points. A higher score indicates better balance function. The reported value is the total scale score (points).

  2. Timed Up and Go Test

    Time frame: 1-month post-intervention (T1), 3-month post-intervention (T2).

    The time required for the subject to rise from a chair, walk 3 meters, turn around, walk back, and sit down is recorded. The reported value is the time to complete the test (seconds). A shorter time indicates better functional mobility.

  3. 6-Minute Walk Test

    Time frame: 1-month post-intervention (T1), 3-month post-intervention (T2).

    The maximum distance a subject can walk on a flat surface within 6 minutes is measured. The reported value is the total walking distance (meters). A greater distance indicates better walking endurance.

  4. Visual Analogue Scale (VAS)

    Time frame: 1-month post-intervention (T1), 3-month post-intervention (T2).

    Assessed using the Visual Analogue Scale (VAS) to evaluate the subject's average pain intensity over the past 24 hours. Subjects mark their pain level on a 10-cm line anchored with "no pain" (0) and "worst pain imaginable" (10). The reported value is the distance from the start point to the mark (centimeters). A higher score indicates more severe pain.

  5. Range of Motion Measurement

    Time frame: 1-month post-intervention (T1), 3-month post-intervention (T2).

    The active range of flexion of the affected hip joint is measured using a universal goniometer. The reported value is the angle of flexion (degrees). A greater angle indicates better joint mobility function.

  6. Psychological Assessment

    Time frame: Baseline (T0), 1-month post-intervention (T1), 3-month post-intervention (T2).

    Assessed using the anxiety subscale (HADS-A) of the Hospital Anxiety and Depression Scale (HADS). This subscale comprises 7 items, each scored from 0 to 3 points. The total score ranges from 0 to 21 points. A higher score indicates more severe anxiety symptoms. The reported value is the total subscale score for anxiety (points).

  7. Proteomics Analysis

    Time frame: Baseline (T0), 1-month post-intervention (T1), 3-month post-intervention (T2).

    Proteomic analysis is performed on fasting venous blood samples to compare protein expression profiles between different time points (T1/T2 vs. T0) and between groups (intervention vs. control). The reported value is the number of statistically significant differentially expressed proteins identified under set significance thresholds (e.g., p<0.05 and fold change >1.5).

Sponsors and collaborators

Lead sponsor

Hai bao

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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